Consumer Lawyers

AOI Cranial Remolding Helmets Warning Letter from FDA

In Uncategorized on June 4, 2012 at 1:44 am

Mr. Mohamad Mansoori
Advanced OrthoPro, Inc.
1820 N. Illinois Street
Indianapolis, IN 46202

Dear Mr. Mansoori:

During an inspection of your firm located in Indianapolis, IN on April 16, 2012, through April 26, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures AOI Cranial Remolding Helmets. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body.

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for developing, conducting, controlling, and monitoring production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). Specifically, your firm does not have a documented process control procedure that describes any process controls necessary to ensure conformance to specifications. Although you provided the investigator with a one page document entitled “Helmet Mold Modification Instructions”, which was developed during the course of the inspection, this document does not meet the requirements listed in 21 CFR 820.70(a)(1-5) in that it does not include: 1) instructions, procedures and methods that define and control the manner of production, 2) the monitoring and control of process parameters, and component and device characteristics during production, 3) compliance with specified reference standards or codes, 4) the approval of processes and process equipment, and 5) criteria for workmanship that is expressed in documented standards or by means of identified and approved representative samples.

2. Failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 C.F.R. § 820.50. Specifically, you have not established: 1) specifications for the raw materials used to manufacture the AOI Cranial Remolding Helmet; and 2) criteria for the selection and evaluation of suppliers.

3. Failure to establish and maintain adequate procedures for acceptance of incoming product, which shall be inspected, tested, or otherwise verified as conforming to specified requirements, as required by 21 CFR 820.80(b). The FDA investigator was told that there is not an established procedure for the acceptance of the incoming raw materials used to manufacturer the AOI Cranial Remolding Helmets.



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