Editor's Note
FDA issued this warning letter to Custom Nutraceuticals, LLC for alleged violations of the current good manufacturing practice (cGMP) regulations, causing FDA to consider several of the company's products to be adulterated. FDA investigators observed that the company allegedly failed to:

  • verify, for a subset of finished dietary supplement batches identified through sound statistical sampling (or for every finished batch), that the finished batch of the dietary supplement meets product specifications for identity, purity, strength, and composition
  • establish and follow laboratory control processes that are reviewed and approved by quality control personnel, for use of criteria for selecting standard reference materials used in performing tests and examinations
  • suitably dispose of label and packaging for dietary supplements that are obsolete or incorrect to ensure that they are not used in any future packaging and label operations.

FDA also alleged that the firm's quality control personnel approved and released for distribution a batch of dietary supplement(s) that did not meet established product specifications. The warning letter stated that FDA has not received a response from the firm concerning the observations noted on the Form FDA 483, Inspectional Observations, which was issued on January 23, 2020. The agency warned that failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
August 2020
Food and Drug Administration

Between January 8, 2020, and January 23, 2020, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement facility located at 69 Mall Drive, Commack, NY 11725. During the inspection, our investigators found significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your Thermal Revolution Black, Anabolic Blackout Raspberry Lemonade, Militia Re-COMP, and Rhino Rampage Wildberry 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)] in that the dietary supplement products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). You can find the Act and the FDA’s regulations through links on FDA’s home page at www.fda.gov.

We have not received a response from your firm concerning the observations noted on the Form FDA 483, Inspectional Observations, which was issued to your firm on January 23, 2020.

During the inspection, we observed the following significant violations of the CGMP regulations for dietary supplements:

1. You failed to verify, for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch), that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, and composition, as required by 21 CFR 111.75(c). Specifically, your firm's product specification sheets for finished product assay testing for Thermal Revolution Black 45 Caps, lot # C191014, exp. 10/22; Anabolic Blackout Raspberry Lemonade, lot # P191068, exp. 10/22; Militia Re-COMP 60 capsules, lot # C190929, exp. 9/22; and Rhino Rampage Wildberry 210g powder, lot # 190893, exp. 8/22 indicates assay testing was based on production input rather than on any type of analytical testing of the finished product. The input of a dietary ingredient alone is not sufficient to verify its specifications for identity, purity, strength, and composition in a finished product. All tests and examinations that are employed to determine whether a specification has been met must be scientifically valid in accordance with 21 CFR 111.75(h)(1). The addition of a dietary ingredient into a product formulation is a manufacturing step; it is not a definitive test method that yields a measured result, nor is it able to assess the ingredient in the finished dietary supplement product when other components are present.

To meet the requirement in 21 CFR 111.75(c), you must provide adequate documentation of your basis for why meeting the specification(s) selected under 21 CFR 111.75(c)(1), through the use of appropriate tests or examinations conducted under 21 CFR 111.75(c)(2), will ensure that your finished batch of dietary supplement meets all product specifications for identity, purity, strength, and composition, as required by 21 CFR 111.75(c)(3), and you must keep documentation for why the result of appropriate tests or examinations for the product specifications selected under 21 CFR 111.75(c)(1) ensure that the dietary supplement meets all product specifications, as required by 21 CFR 111.95(b)(4).

2. Your firm failed to establish and follow laboratory control processes that are reviewed and approved by quality control personnel, for use of criteria for selecting standard reference materials used in performing tests and examinations, as required by 21 CFR 111.315(d). Specifically, you do not have the proper laboratory controls in place to conduct the (b)(4) which includes the use of criteria for selecting reference standard materials used in performing tests and examinations. The raw material identification test that you use for (b)(4), was not compared to a reference standard.

3. Your quality control personnel approved and released for distribution a batch of dietary supplement(s) that did not meet established product specifications in accordance with 21 CFR 111.70(e), in violation of 21 CFR 111.123(b)(2). Specifically, your batch production record for Militia Re-COMP 60 Capsules, lot # C190929 documents that the ingredient, (b)(4) went into the finished batch of dietary supplements; however, your raw material test results indicates it was the ingredient, (b)(4) that actually went into the finished batch.

4. You failed to suitably dispose of label and packaging for dietary supplements that are obsolete or incorrect to ensure that they are not used in any future packaging and label operations, as required by 21 CFR 111.415(h). Specifically, the labels for your Anabolic Blackout Raspberry Lemonade Lot P191068 lists (b)(4) in the ingredient list; however, you stated during the inspection that you were unable to obtain this ingredient, but you continued to use this incorrect label.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility or in connection with your products. 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 that your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Sections 302 and 304 of the Act provide for seizure of violative products and injunction against the manufacturers and distributors of violative products [21 U.S.C. §§ 332 and 334].

Within fifteen working days of the receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

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.

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