Consumer Lawyers

Archive for January, 2012|Monthly archive page

Rexall recalls calcium supplements

In Uncategorized on January 25, 2012 at 8:08 pm

Rexall Inc. in Deerfield Beach recalled more than 13,500 bottles of calcium soft-gel capsules because they mistakenly were filled with tablets of the wrong product.

A company spokesman said Tuesday the recall involves 60-capsule bottles of Rexall Calcium 1200 mg plus 1000IU Vitamin D3, sold at Dollar General. The glucosamine tablets mistakenly put in the bottles are made from shellfish that can cause allergic reactions.

No illnesses have been reported, and the company said many of the bottles were removed before they were distributed to retail stores.

The affected bottles carry the UPC code 3 01220 45211 3, expiration date 8/15 and lot number 387651-04. Return for a refund. Information: 888-534-6370 or fda.gov/safety/recalls.

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Quinault fish plant conditions lead to FDA recall (January 25, 2012)

In Uncategorized on January 25, 2012 at 8:06 pm

Before a federal inspection forced a recall last spring of almost 27,000 cans of fish processed at a Quinault Nation plant, Quinault Vice Chairman Andrew Mail ate 36 cans of the stuff.

He didn’t get botulism. But the U.S. Food and Drug Administration says the recall may have avoided a food-poisoning outbreak. FDA lab tests showed that faulty seals and cooking irregularities allowed dangerous microorganisms to grow in canned and smoked salmon, sturgeon, razor clams and tuna processed at the plant. Investigators also wrote in a November warning letter that they found rodent and bird droppings, cat hair, feathers and insect larvae there.

 

Read more here.

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Kradjian Imp Co: Recall Of Cedar Tree Brand Tresse Cheese And Cedar Tree Brand Shinglish Cheese

In Uncategorized on January 25, 2012 at 8:02 pm

Kradjian Imp Co, Glendale, CA is recalling 231 Cases, 22Lb / Cs of Cedar Tree  brand Tresse Cheese, 16 oz and Cedar Tree brand Shinglish cheese, 16 oz because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Tresse Cheese and Shinglish cheese were distributed in Southern California, Northern California, Washington State, Minnesota, Nevada, Oklahoma, Texas, Tennessee,Arizona and Michigan to Mediterranean specialty markets.

Both cheeses Cedar brand Shinglish firm unripened cheese, delivered before November 13, 2011 UPC: 78546 10000 and Cedar brand Tresse firm unripened cheese, delivered before November 13, 2011 UPC 78546 01000 were manufactured and recalled by Fromagerie Marie Kade, in Quebec Canada.  Both cheeses are vacuum packed and bear the picture of a green cedar tree, pictured at http://www.fromageriemariekade.com/Produits.htm disclaimer icon.

Kradjian has recently been notified by our supplier that the above lot number of this product has the potential to be contaminated with Listeria monocytogenes.

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1/25/2012: CareFusion Update of Recall of Neurological Monitoring Software and Devices

In Uncategorized on January 25, 2012 at 7:59 pm

CareFusion issued the following update regarding its voluntary recall of the Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License. The FDA has classified this action as a Class I recall.

The company initiated the voluntary recall, which affects 125 devices and 58 software licenses, in October 2011. The devices and software subject to the recall were distributed to 38 customers between May 7, 2009 and July 11, 2011. This action has no effect on the manufacture or distribution of current products.

There is no change to the remediation plan previously communicated by the company. CareFusion has already completed the majority of the corrective actions on affected products in the United States.

In October 2011, the company sent an urgent Medical Device Recall Notification to customers stating the identified potential risks associated with the Cortical Stimulator Control Unit, SSU Amplifier and related software applications. Affected units have the potential to develop a short circuit, and affected software licenses may display or capture the incorrect electrode annotation label on the Cortical Stimulator Control Unit screen and in the associated report. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units.

In the notification letter, customers were provided serial and version numbers of affected hardware and software. This information is available at http://www.carefusion.com/customer-support/alerts-notices/medical-device-recall-nicoletone-software.aspx .

Instructions to customersCustomer inquiries related to this action should be addressed to the CareFusion NeuroCare Call Center at 800-356-0007 (press option 2 for Technical Support).

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program: by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787; by phone at 1-800-332-1088; by fax at 1-800.FDA.0178 or at http://www.fda.gov/medwatch

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Gilenya Investigated after 11 deaths

In Uncategorized on January 23, 2012 at 10:36 pm

A European agency is investigating a multiple sclerosis drug made by industry giant Novartis to determine whether the medicine played any role in the deaths at least 11 patients.

The drug, Gilenya, was licensed last year in the European Union to treat a severe type of multiple sclerosis. It can cause a slow heart rate when first taken and doctors closely monitor patients after the first dose.

The European Medicines Agency, which is now investigating the drug, said it isn’t clear if it caused the deaths. One of the fatalities occurred in the United States, where a patient died within 24 hours of taking the first dose.

The European agency said it didn’t know where the other 10 deaths occurred, but that they were reported to its drug database, which monitors side effects from medicines in the European Union.
Novartis said not all the deaths were heart related.

Source: http://finance.yahoo.com/news/Novartis-drug-investigated-11-apf-2058543292.html?x=0

Jan 11 2012 Heart attack risk seen with clot drug Pradaxa

In Uncategorized on January 13, 2012 at 3:51 am

Not a recall, but news for mid week:

Boehringer Ingelheim’s Pradaxa blood clot preventer has been associated with a slightly higher risk of heart attack or acute coronary syndrome, according to results of a meta-analysis of several studies reported in a major medical journal.

The relative increase in risk to comparative medicines was found to range from 27 to 33 percent, however the absolute risk increase for suffering a heart attack was only 0.27 percent, the authors of the meta-analysis said in the study published on Monday in the Archives of Internal Medicine online edition.

Pradaxa, known chemically as dabigatran, is approved in the United States for stroke prevention in patients suffering from an irregular heart beat known as atrial fibrillation, and in Europe to prevent strokes caused by blood clots in patients who have undergone hip and knee replacements.

 

http://www.reuters.com/article/2012/01/09/us-heartattack-pradaxa-idUSTRE8082CX20120109

Jan 8, 2012: FDA Recall of Ikiaria INOMax DS

In Uncategorized on January 8, 2012 at 2:25 pm

The FDA has issued a Class 1 recall of the Ikaria INOmax DS Drug Delivery System.

The recalled drug delivery system is used with ventilators to deliver a preset concentration of INOmax therapy gas (nitric oxide for inhalation) for critically ill patients.

Healthcare professionals were told to stop using the product after the FDA discovered corrosion at its electrical contacts could cause erratic readings of nitric oxide monitors. The consequences of the defect include inadequate oxygen reaching the tissues in the body, low blood pressure, a slowed heart rate, cardiac arrest, organ damage, acute respiratory distress syndrome, and neurological deficits. In more serious cases, the defect can lead to death.

From the FDA site: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm285803.htm?source=govdelivery

ISSUE: FDA notified healthcare professionals of a Class I recall of Ikaria INOmax DS Drug Delivery System. Erratic nitric oxide (NO) monitoring readings were being caused by fretting corrosion at the electrical contact interface of certain metals. Adverse consequences may include inadequate oxygen reaching the tissues in the body (hypoxia), low blood pressure (hypotension), slower than normal heart rate (bradycardia), cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death.

Affected serial numbers include DS20070005-DS20100865. This product was manufactured from March 12, 2007 through February 2, 2011 and distributed from September 4, 2007 through February 2, 2011.

BACKGROUND: INOmax DS Delivery System is a drug delivery system used with ventilators to deliver a preset concentration of INOmax therapy gas (nitric oxide for inhalation) for critically ill patients.

RECOMMENDATION: Ikaria implemented a service process change involving the application of DeoxIT, an anti-corrosion lubricant specifically created to prevent fretting corrosion. DeoxIT was added to the preventive maintenance plan for all INOmax DS Drug Delivery Systems and was performed when the Systems rotated through Ikaria’s Regional Service Centers for any routine service activity.

January 5, 2012: FDA Recalls Fluzone Vaccine

In Uncategorized on January 8, 2012 at 2:21 pm

PRODUCT
Fluzone(R), Influenza Virus Vaccine, Single-Dose Vials, 0.5 mL, NDC 49281-011-10. Recall # B-0460-12

CODE
Lot numbers U4114DA, exp 6/30/12; U4118AA, exp 6/30/12; U4118BA, exp 6/30/12; U4118BB, exp 6/30/12; U4122AA, exp 6/30/12; U4122BA, exp 6/30/12; U4122CA, exp 6/30/12; U4124AA, exp 6/30/12; U4124BA, exp 6/30/12; U4124CA, exp 6/30/12; U4147AA, exp 6/30/12; U4147BA, exp 6/30/12; U4147CA, exp 6/30/12; U4149AA, exp 6/30/12; U4159DA, exp 6/30/12; U4178AA, exp 6/30/12; U4178BA, exp 6/30/12; U4184AA, exp 6/30/12; and U4197AB, exp 6/30/12

RECALLING FIRM/MANUFACTURER
Sanofi Pasteur, Inc., Swiftwater, PA, by letter on November 14, 2011. Firm initiated recall is ongoing.

REASON
Fluzone(R), Influenza Virus Vaccine, Single-Dose Vials, 0.5mL, misbranded due to an error in the Prescribing Information (PI) included in packages of 10 single-dose vials of Fluzone vaccine, was distributed.

VOLUME OF PRODUCT IN COMMERCE
2,832,810 units

DISTRIBUTION
Nationwide

___________________________________________________________________________
Fluzone is an inactivated, injected vaccine. It is the only vaccine on the market approved for ages 6 months and older

 

Source: http://guggiedaly.blogspot.com/2012/01/fda-recalls-fluzone-vaccine-jan-4-2012.html

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J&J Halts Study of Doribax Antibiotic – Higher Death Rate

In Uncategorized on January 8, 2012 at 1:28 am

J and j  halted a clinical trial of its antibiotic Doribax after more pneumonia patients who took the product died and fewer were cured, regulators said.

Doribax, already approved for urinary and abdominal infections in the U.S., is still considered safe and effective for those uses, the FDA said on its website. The trial tested the drug in pneumonia patients who were on ventilators, an indication for which it’s approved in Europe.

 

The U.S. Food and Drug Administration (FDA) is informing the public that a recent clinical trial with Doribax (doripenem) was stopped early because of significant safety concerns. This trial, which was evaluating the effects of Doribax on treatment of patients with ventilator-associated pneumonia, demonstrated excess mortality and a numerically poorer clinical cure rate among subjects treated with Doribax compared to those treated with imipenem-cilastatin. FDA is reviewing the trial results and will communicate any new information that results from this investigation.

Healthcare professionals should be aware that Doribax is not approved to treat any type of pneumonia, nor is it approved for doses greater than 500 mg every eight hours. 

Doribax is still considered safe and effective for its approved indications–treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections including pyelonephritis. The recommended dose of Doribax is 500 mg every eight hours intravenously, given over 1 hour, for a total of 5-14 days (depending on indication) in adults.

According to Janssen Research and Development LLC (Doribax’s manufacturer), Table 1 below shows the interim results for both clinical cure rates and 28-day all-cause mortality rates for the Microbiological Intent-to-Treat (MITT) population and the Microbiologically Evaluable (ME) population.

Table 1. Summary of Clinical Cure Rates and All-Cause 28-Day Mortality Rate

 

Analysis Population Doripenem
Group
%
Imipenem
Group
%
Difference

%

2-sided 95%
CI
%
Clinical Cure Rates
MITT 45.6 56.8 -11.2 -26.3 to 3.8
ME 49.1 66.1 -17 -34.7 to 0.8
All Cause 28-day Mortality Rate (MITT) 21.5 14.8 6.7 -5.0 to 18.5

 

 

link:http://www.bloomberg.com/news/2012-01-05/j-j-halts-study-of-doribax-antibiotic-on-higher-death-rate.html

Ion Labs Warning Letter Dec 2011

In Uncategorized on January 5, 2012 at 3:57 am
Terry E. Oliver, CEO
Ion Labs, Inc.
5475 115th Ave. N
Clearwater, FL 33760
 
Dear Ms. Oliver:
 
From April 19, 2011 to June 03, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 5475 115th Ave. N, Clearwater, Florida.  Our investigation revealed significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). At the conclusion of the inspection, you were issued a Form FDA 483, List of Inspectional Observations, which lists a number of the violations that cause the products manufactured in your facility to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that these dietary supplements have been prepared, packed, or held under conditions that do not meet current good manufacturing practice requirements for dietary supplements.  You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
 
The inspection revealed the following violations:

1.    Your firm failed to verify that your finished batch of dietary supplements met established product specifications for purity and strength, as required by 21 CFR 111.75(c). You must establish product specifications for each dietary supplement you manufacture (21 CFR 111.70(e)), and determine whether these specifications are met (21 CFR 111.73) by testing the finished batch of dietary supplement in accordance with testing requirements in 21 CFR 111.75(c). Specifically, you provided our investigator with finished assay test data on the products you manufacture, including assay data on product FaBB (batch# 030013 and 030014). However, our review of the assay data revealed that they were insufficient to meet this requirement. Your assay data did not provide quantitative data to determine if the specifications for your finished products were met. Further, the concentration (strength) for the referenced standards was not provided.

We reviewed your response and exhibits 1-4 dated June 23, 2011 and found it to be inadequate. You submitted a standard operating procedure (SOP) entitled “Minimum Finished Product Testing Requirements for Nutritional  Product.” However, this SOP appears to only address the identity requirement. It does not address your responsibility to verify the purity, strength, and composition specifications of your finished products. You also submitted finished product specification sheets for the products Kidney Cleanse, Liver Cleanse, Slim System, and Natural Moves. However, these product specification sheets do not list the required specifications under 21 CFR 111.70(e). 

2.    You failed to establish laboratory control processes that are reviewed and approved by quality control personnel, including the use of criteria for selecting reference materials used in performing tests and examination, as required by 21 CFR 111.315(d). Specifically, you indicated to our investigators during the inspection that your non-compendia reference standard materials (i.e., spectrum graphs) for the (b)(4) transform infrared spectroscopy ((b)(4)TIR) are selected from previous component shipments received and analyzed by your (b)(4)TIR equipment. However, you failed to establish any criteria (i.e., characterization) to establish a reference standard. Non-compendia reference standard materials should be of the highest purity by reasonable effort and should be thoroughly characterized to ensure their identity, purity, quality, and strength.[OGC1]

We reviewed your June 23, 2011 response and you did not further address the investigator’s observation regarding the (b)(4)TIR scan. 

3.    You reprocessed dietary supplements, but failed to have quality control personnel conduct a material review and make a disposition decision that is based on a scientifically valid reason and approve the reprocessing, as required by 21 CFR 111.90(b)(1). The person who conducts a material review and makes the disposition decision must document that at the time of performance [21 CFR 111.113(b)(2)], and you are required to make and keep these records [21 CFR 111.140(b)(3)]. Specifically, you were unable to produce documentation that quality control personnel conducted a material review, made a disposition decision, and approved the reprocessing of the following:

  • Slim System tablets, batch # 020194, failed its tablet specifications (e.g., hardness) due to “flow” issues during tablet compression and the product was reprocessed. You indicated to our investigators that the product was reprocessed by a process called (b)(4)
  • Ion Kidney Flush tablets, batch # 12005, failed its tablet specification (e.g., hardness) due to flow issues during tablet compression and the product was reprocessed.
We reviewed your response and exhibits dated June 23, 2011 and found it to be inadequate. You submitted a blank “(b)(4) form,” as an exhibit, but it does not specifically correct this violation. Further, you provided no documentation to show a material review and disposition decision prior to any reprocessing of the dietary supplements.   

4.    Your firm’s batch production records do not include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 111.260. For example, the batch records for Zen Cleanse Liver Cleanser (batch # 020336), Zen Cleanse Kidney Cleanser (batch # 120005), Prostate Men’s Health (batch # 020321), Vita Trum SR (batch #020371), and Vita-TRUM 50 + (batch # 020268) lack the batch production information related to the tablet coating of these products. Your Master Formula for these products indicated that these tablets were coated and that some were outsourced for coating. However, there is no information in your batch records to show the coating process of these tablets.

We reviewed your response dated June 23, 2011 and found it to be inadequate. You did not include any procedure or documentation on how these products were coated.

5.    Your firm did not establish specifications for each component that you use in the manufacture of your dietary supplements, including (1) an identity specification; (2) component specifications that are necessary to ensure that specifications that are necessary to ensure that the specifications for the purity, strength and composition of dietary supplements manufactured using the components are met; and (3) limits on those types of contamination that may adulterate or may lead to adulteration on the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required in 21 CFR 111.70(b). For example, your firm failed to establish identity, purity, strength, and composition specifications for the Vitamin A Acetate 500,000 IU (ION Labs Raw Material Test Ticket date received 1/17/11) and Choline Bitartrate (ION Labs Raw Material Test Ticket date received 9/9/10) used in the manufacture of your dietary supplements. These Test Tickets list some tests and specifications, but the specifications listed did not meet the requirements under 21 CFR 111.70(b) for the purity and composition specifications of the components, and, as applicable, limits on the types of contamination that may adulterate or may lead to adulteration of the finished products.   

We reviewed your June 23, 2011 response and exhibits 7-10 and found them to be inadequate. For example, we reviewed your raw material specification sheets for magnesium stearate and isomalt. Based on our review, your firm failed to establish the identity, purity, strength, and composition specifications for these components you use to manufacture your dietary supplements. 
 
6.    Your quality control personnel failed to conduct a material review and make a disposition decision when a batch deviates from the master manufacturing record (MMR), including when any step established in the master manufacturing record is not completed and including deviations from specifications as required by 21 CFR 111.113(a)(2).  You are required to make and keep documentation of any material review and disposition decision and follow-up [21 CFR 111.140(b)(3)]. Such documentation must meet the requirements of 21 CFR 111.140(b)(3), including an identification of the specific deviation or the unanticipated occurrence [21 CFR 111.140(b)(3)(i)]; a description of your investigation into the cause of the deviation from the specification or the unanticipated occurrence [21 CFR 111.140(b)(3)(ii)]; an evaluation of whether or not the  deviation or unexpected occurrence has resulted in or could lead to a failure to ensure the quality of the dietary supplement [21 CFR 11.140(b)(3)(iii)]; the identification of the actions taken to correct, and prevent a recurrence of, the deviation or unanticipated occurrence [21 CPR 111.140(b)(3)(iv); an explanation of what you did with the component, dietary supplement, packaging, or label [21 CFR 111.140(b)(3)(v)]; and a scientifically valid reason for any reprocessing of a dietary supplement that is rejected or any treatment or in-process adjustment of a component that is rejected [21 CFR 111.140(b)(3)(vi)].
 
Specifically, the following batches deviated from the MMR, and you did not provide documentation of any material review and disposition decision and follow up for these deviations.:
  • Zen Cleanse Liver Cleanse, batch # 020336 deviated from the MMR in that Choline Bitartrate 1% powder was replaced with Choline Bitartrate 41% powder.
  • Natural Moves, batch # 020331 deviated from the MMR in that calcium carbonate was added to the batch, but not part of the MMR. Also, additional amounts of microcrystalline cellulose were added beyond the amount listed in the MMR.
  • Wintergreen ContentMints, batch # 020305 deviated from the MMR in that additional amount of 1% of Magnesium Stearate Powder was added to the batch.

7.    When a dietary supplement does not meet a specification established in accordance with 21 CFR 111.70(a), quality control personnel must reject the dietary supplement, unless quality control personnel approve a treatment, an in-process adjustment, or reprocessing, as permitted in 21 CFR 111.77 [21 CFR 111.77(a) and 111.113(b)(2)]. However, your firm’s quality control personnel approved the release of the following finished batches of product that did not meet specifications established under 111.70(a):

  • Native Remedies Natural Moves, batch # 020331, when finished product specification failed for tablet hardness, as referenced in your ION Labs Test Ticket (Compression Startup Check) dated 1/5/11.
  • Calming Essence ContentMints, batch # 020305, when finished product specification failed for tablet hardness, as referenced in your ION Labs Test Ticket (Compression Startup Check) dated 12/14/10.
  • Ribbon Nutrition Pure IGP, batch # 020311, when finished product specification for tablet hardness, as referenced in your ION Labs Test Ticket (Compression Startup Check) dated 12/1/10.
We reviewed your June 23, 2011 response to Observation 4 and found it to be inadequate. Your response addressed that you will re-train your quality control personnel on Out of Specification procedures, but it did not address why your quality control personnel did not reject out of specification products. 
 
We reviewed your response dated June 23, 2011 and found it to be inadequate. You did not include documentation of any material review and disposition decision regarding these deviations. 

8.    Your firm’s Master Formula (Master Manufacturing Records (MMR)) for the Vitra TrumSR, Vita-TRUM 50+ Multi, Prematria Prenatal, Kidney Flush, Ion Liver Flush, and Prostate Health products did not include the following information required by 21 CFR 111.210:

  • A statement of the expected yield of the manufactured dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted, and disposition decision is made. [21 CFR 111.210(f)].
  • A description of packaging and a representative label or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)].
  • Written instructions, including:
o       Specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR [21 CFR 111.210(h (1)].  Specifically, these tablets products are coated, but there are no coating specifications (e.g., coating type) listed in your master formula.
 
o       Procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)].
 
o       Written instructions, including specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record [21 CFR 111.210(h)(3)].
 
o       Corrective action plans for use when a specification is not met [21 CFR 111.210(h)(5)]. 
 
This letter is not an all-inclusive list of violations at your facility.  It is your responsibility to ensure that your establishment and the products you market comply with the Act and its implementing regulations.
 
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
 
Please advice this office in writing within 15 days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not recur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, explain the reason for the delay and the date by which you will complete the corrections.
 
Your response should be sent to: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact: Mr. Alejo at            (407) 475-4731      .
 
Sincerely,
/S/                                                          
Emma R. Singleton
Director, Florida District