WARNING LETTER
Armada Nutrition MARCS-CMS 523876 —
- Recipient:
-
Recipient NamePresident
- Armada Nutrition
4637 Port Royal Rd
Spring Hill, TN 37174-2834
United States
- Issuing Office:
- Cincinnati District Office
United States
Cincinnati District Office 6751 Steger Drive Cincinnati, OH 45237 Telephone: (513) 679-2700 FAX: (513) 679-2772
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August 1, 2017
Warning letter 523876
UNITED PARCEL SERVICE
Delivery Signature Requested
Brent A. Laffey, President
Armada Nutrition LLC
4637 Port Royal Road
Spring Hill, Tennessee 37174
Dear Mr. Laffey:
On March 13-17, 20, 22, and 24, 2017, investigators with the U.S. Food and Drug Administration (FDA) conducted an inspection of your firm, located at 4637 Port Royal Road, Spring Hill, Tennessee. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations, Part 111 (21 CFR part 111). These violations cause your dietary supplement products 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)] because they have been prepared, packed, or held under conditions that do not meet CGMP regulation for dietary supplements. You may find the Act and FDA regulations through links on FDA’s Internet home page at www.fda.gov.
During our inspection of your facility, our investigator’s observations were noted on a Form FDA 483, Inspectional Observations, which was issued to you on March 24, 2017. We received a written response from Moriah Seibert, Director of Quality, on behalf of your firm, dated April 13, 2017, concerning the observations noted on the FDA 483. We address each of your relevant responses below in relation to each of the noted violations. The significant violations documented during the inspection include, but are not limited to, the following:
1. You failed to establish and follow 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 111.303. Specifically, your firm failed to establish and maintain SOPs for the tests and examinations that you conduct using your (b)(4) and (b)(4), used for identity testing on incoming ingredients, in-process materials, and finished products.
We reviewed your firm’s response dated April 13, 2017, but we are unable to evaluate the adequacy of your corrective action. You stated that your firm is in the process of establishing SOPs, which will be completed by October 1, 2017. However, you did not provide documentation regarding how your firm will ensure the adequate laboratory operations in the meantime (i.e., until October 1, 2017).
2. You failed to calibrate instruments and controls that you use in testing a component or dietary supplement, as required under 21 CFR 111.27(b). Specifically, your (b)(4), used for identity testing on incoming ingredients, in-process materials, and finished products, have not been calibrated since beginning operations in July 2016.
We reviewed your firm’s response dated April 13, 2017, but we are unable to evaluate the adequacy of your corrective action. You stated that your firm is in the process of establishing purchase orders for equipment calibration and preventive maintenance. However, you did not provide documentation regarding how your firm will ensure your (b)(4) will be calibrated properly in the meantime (i.e., until October 1, 2017).
3. Your firm failed to take necessary precautions during the manufacture of a dietary supplement to prevent contamination of components or dietary supplements, including performing manufacturing operations under conditions and controls that protect against the potential for growth of microorganisms and the potential for contamination, as required by 21 CFR 111.365(a). Specifically, on March 15, 2017, our investigators observed the following conditions in the production/fill suite 3 during production:
a. An employee was observed vacuuming the floor of debris that had fallen off a blended finished product bag (Lot 493572). Then the same employee used the same vacuum nozzle to vacuum the underside of an ingredient bag. The ingredient bag was then lifted into the hopper and its contents emptied into the filler. The ingredient bag was a large nylon bag with a tie closure on the bottom from which the contents were emptied into a hopper.
b. An employee removed a plexiglass cover from the top of a filler and placed the cover directly on the floor during the filling of the hopper after which the cover was placed back on top of the filler hopper.
We reviewed your response dated April 13, 2017; however we are unable to evaluate the adequacy of your corrective action. You stated both situations have been corrected; and, continued correction will be verified by weekly internal audits and during all cleaning inspections. However, you failed to provide supporting documentation.
This letter is not an intended to be an all-inclusive list of violations in connection with your products or their labeling. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your establishment and your products comply with the Act and its implementing regulations. You should take prompt action to correct all violations noted in this letter.
Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction.
Additionally, we offer the following comment. We acknowledge that you have voluntarily recalled your dietary supplement product, Performix Crea-Bead, lot IM447128, after our investigators found your firm failed to reject the component Creatine monohydrate, Lot 20160226, after your contract laboratory identified Staphylococcus aureus in the component. In your response, dated April 13, 2017, you indicate “[T]o correct this observation going forward, the OOS investigation and reporting process will be redefined and rewritten in SOP form by June 1, 2017. Effective immediately, all OOS investigation reports will be signed off by a director level position or above to ensure proper actions are taken to release, return, or destroy materials that are investigated.” We plan to assess the adequacy of the revised SOP during the next inspection.
Please respond to this office in writing within 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 corrective actions. If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the time within which you will complete the corrections.
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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Stephen J. Rabe, Compliance Officer, at the address in the letterhead or via email at stephen.rabe@fda.hhs.gov. If you have questions, please contact Mr. Rabe at 513-679-2700 extension 2163.
Sincerely,
/S/
Kimberly L. McMillan
Acting Director, Cincinnati District
cc: (b)(4)
Moriah Seibert, Director of Quality
Armada Nutrition LLC
4637 Port Royal Road
Spring Hill, Tennessee 37174