Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
November 15, 2012
Jack Lee Davis, President/Owner
Health Technology, Inc.
655 Crawford Street
Dawson, GA 39842
Dear Mr. Davis:
From May 8 to 16, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 655 Crawford Street in Dawson, Georgia. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, found in Title 21 of the Code of Federal Regulations, Part III (21 CFR Part 111). These violations render your dietary supplements adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(g)(1)], in that the products were prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. The inspection also revealed violations of dietary supplement labeling requirements, rendering your products Professional Choice Pycnogenol, Natural Solutions Memory, and Super-Imuno Plus misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)].
During the inspection, you informed us that your firm ‘s revenue is generated primarily by contract manufacturing dietary supplements for customers using customer-provided mix or formulations. Your firm’s status as a contract manufacturer does not exempt you from having to comply with those regulations in 21 CFR Part III that are directly applicable to the operations that you perform.
Dietary Supplement CGMP Violations
1) Your firm failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch as required by 21 CFR 111.205(a). Specifically, you manufacture approximately (b)(4) dietary supplements; however, you did not prepare MMRs for any of the dietary supplements you manufacture, as required by 21 CFR 111.210.
2) Your firm failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement for each dietary supplement that you manufacture, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement as required by 21 CFR 111.70(e).
We note that once you have established the above specifications, you must determine whether the specifications have been met as required by 21 CFR 111.75.
3) Your firm failed to make and keep written records for the production and process control system requirements that apply to components, packaging, and labels, as required by 21 CFR 111.180.
• You failed to maintain written procedures for receiving components, packaging, or labeling. In addition, you do not have any written procedures for rejected components, packaging, or labels. (21 CFR 111.180(b)(1)].
• You failed to maintain any documentation of the examination of raw materials, including components, packaging, or labels received for the production of dietary supplements. (21 CFR 111.180(b)(3)].
4) Your firm failed to make and keep written records for the requirements that apply to equipment.
• You did not make and keep written records of your written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement. [21 CFR 111.35(b)(1)(i)]. Moreover, you did not make and keep records documenting the calibration, each time the calibration is performed, for instruments and controls that you use in manufacturing or testing a component or dietary supplement. [21 CFR 111.35(b)(3)].
• You did not make and keep written records of your written procedures for maintaining, cleaning, and sanitizing as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements. (21 CFR 111.35(b)(l)(iii)].
5) Your firm failed to make and keep written records of your written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision and written procedures for approving and rejecting any reprocessing, as required by 21 CFR 111.140(b)(1).
6) Your firm failed to make and keep written records of your written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met, as required by 21 CFR 111.325(b)(1).
7) Your firm failed to make and keep written records of your written procedures for fulfilling the requirements that apply to the review and investigation of product complaints, as required by 21 CFR 111.570(b)(l).
8) Your firm failed to make and keep written records of your written procedures for cleaning the physical plant and for pest control, as required by 21 CFR 111.23 (b).
9) Your firm must not use insecticides, fumigants, fungicides, or rodenticides, unless you take precautions to protect against the contamination of components, dietary supplements, or contact surfaces as required by 21 CFR 111.15(d)(3). However, for pest control, you use (b)(4) brand (b)(4) an insecticide that is not approved for use in a food manufacturing facility.
Misbranding of Dietary Supplements
Your Professional Choice Pycnogenol, Natural Solutions Memory, and Super-Imuno Plus products are misbranded within the meaning of 403(y) of the Act [21 U.S.C. § 343(y)] because the labels fail to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplements. “Domestic address or domestic phone number” means a complete address or phone number. The labels for these three products do not include complete addresses or phone numbers.
We have reviewed your written response dated May 30, 2012 to the Form FDA 483, Inspectional Observations, issued to you at the close of the inspection and determined that the response is inadequate in that it fails to address the violations noted, particularly in relation to your firm’s complete lack of documentation and written procedures as required by the CGMP regulation for dietary supplements.
This letter is not intended to be an all-inclusive list of violations that may exist at your facility. It is your responsibility to ensure that the products you manufacture are in compliance with all requirements of the Act and pertinent FDA regulations, such as the dietary supplement regulations (21 CFR Part 111). You can find copies of the Act and pertinent regulations through links on FDA’s homepage at www.fda.gov.
In addition to the violations cited above, we have the following comment:
• Under 21 CFR 111.14(b )( 1 ), your firm must make and keep written records of written procedures for fulfilling the requirements that apply to preventing microbial contamination from sick or infected personnel, for hygienic practices, and for personnel qualifications. We note that your firm does not currently have such procedures.
You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective actions may result in FDA taking regulatory action, such as seizure or injunction, without further notice.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above-noted violations and prevent similar ones. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the corrections.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Lakisha N. Morton, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Mrs. Morton at 404-253-1285 or write her at the noted address.
This page was posted on November 30, 2014.