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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Farouk Systems, Inc. 01-Aug-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

Food and Drug Administration
Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204

August 1, 2001

Ref: 2001 -DAL-WL-33
WARNING LETTER
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Farouk M. Shami, President/CEO
Farouk Systems, Inc.
250 Pennbright
Houston, TX 77090

Dear Mr. Shami:

On May 29/30 and June 4, 2001, a FDA investigator conducted an establishment inspection of your drug and cosmetic manufacturing firm. The investigator determined that your firm manufactures and distributes "Biosilk" Dandruff Control Shampoo and Conditioners, and the "Power Plus" - Hair Loss Prevention System, consisting of Priming and Vitalizing Shampoos, Stimulating Conditioner, Energy Nutrient Supplements, and Root Booster. Labeling for the Biosilk Dandruff Control products establishes their intended use in the treatment of dandruff. Labeling of the Power Plus - Hair Loss Prevention System and the various components (sold separately or in a kit) promotes hair growth and reduction of excessive hair loss, and indicates that hair treatment promotes microcirculation of blood to enhance the follicle to grow hair stronger, faster, and retention of hair longer. These products meet the definition of drugs under Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act).

During the inspection, the investigator documented significant deviations from the Current Good Manufacturing Practices for Finished Pharmaceuticals -Title 21, Code of Federal Regulations, Parts 210 and 211 (CGMPS). Pursuant to Section 501(a)(2)(B) of the Act, a drug is adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practices to ensure that such drug meets the requirements of the Act as to safety and has the identity and strength, and meets the quality and purity characteristic, which it purports or is represented to possess.

The investigator issued a List of Inspectional Observations (Form FDA 483) to you at the conclusion of the inspection. The FDA 483 identified many production, process, and operational control deficiencies causing the drug products manufactured by your firm to be adulterated.

For example, you have failed to establish and document in writing the responsibilities and authority of a Quality Control Unit designed to assure the quality and purity of each batch of drug product (21 CFR 211.22). You have failed to train employees in CGMPS relative to their job functions in drug production [21 CFR 211.25(a)]. You have failed to validate, for example, the: drug production processes (21 CFR 211.100); computerized control systems used for maintaining laboratory data and drug product distribution information (21 CFR 211.68); and the cleaning process for common equipment used in drug and cosmetic production processes (21 CFR 21 1.67).

Additionally, you have failed to establish written operating procedures for drug production and process control steps. For example, for receipt and handling of drug components and containers (21 CFR 21 1.80); providing assurance of drug product quality and purity (21CFR 21 1.100); in-process sampling and testing (21 CFR 211.110); packaging and labeling controls (21 CFR 211.122 and 125); laboratory controls (21 CFR211. 160, 165, and 166); and complaint handling procedures (21CFR 211.198).

The observations listed on the FDA 483 are not intended to be an all-inclusive list of the violations and deficiencies that may exist at your firm. It is your responsibility to ensure that all of your drug products are in compliance with federal law and regulations. Federal agencies are advised of the issuance of all warning letters about drugs so that they may take this information into account when considering the award of contracts.

You should notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed. Failure to promptly correct these deviations may result in enforcement action being initiated without further notice. Possible actions include seizure and/or injunction. Please direct your response to James R. Lahar, Compliance Officer at the above address.

Sincerely,

/s/

Dallas District Director

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