Inspections, Compliance, Enforcement, and Criminal Investigations
ABH Nature's Products, Inc. 10/24/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433
October 24, 2012
WARNING LETTER NYK-DO 2013-2
Dr. Jahirul Islam, President
ABH Nature’s Products, Inc.
1885 New Highway
Farmingdale, NY 11735
Dear Dr. Islam:
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located at 1885 New Highway, Farmingdale, New York on June 6 through June 12, 2012. We found serious violations of the Current Good Manufacturing Practice (CGMP) regulation 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 Cal-Mag and Raspberry Ketone 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 supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
In addition, we have reviewed the labeling for your products and based on our review, we have concluded that your product, Raspberry Ketones, is in violation of section 403 of the Act [21 U.S.C. § 343] and the regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101. You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
The inspection revealed the following significant violations:
Dietary Supplement CGMP Violations:
- You failed to establish and follow laboratory control processes that are reviewed and approved by quality control personnel, including the use of criteria for selecting standard reference materials used in performing tests and examinations, as required by 21 CFR 111.315(d). Standard reference materials generally include compendia reference standards that do not require characterization and noncompendia standards that should be of the highest purity that can be obtained by a reasonable effort and should be thoroughly characterized to ensure their identity, purity, quality, and strength (72 Fed. Reg. 34752, 34893 (June 25, 2007)). However, your raw material test/release records show that you are using previously received lots as identity standards for testing dietary ingredients, including Magnesium Oxide (lot #3501), which is used in the manufacture of your Cal-Mag tablets, rather than standard reference materials. Furthermore, these records indicate that the spectrum for your (b)(4) identity test is compared to the previous lot rather than a standard reference material.
We received your written response to the FDA 483 dated June 25, 2012 and have found that it does not adequately address this violation. Specifically, your response states that you have revised your SOP #15-017 to include an in-house secondary standard; however, your response does not adequately document that you are using the secondary standard in your raw material identity testing.
- You failed to qualify component suppliers by establishing the reliability of the suppliers’ certificates of analysis through confirmation of the results of their tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). Specifically, you rely on your suppliers’ certificates of analysis to ensure that microbial and heavy metal specifications are met for the dietary components Calcium Citrate, Magnesium Oxide, Zinc Oxide, and Vitamin D3, which are used in the manufacture of Cal-Mag tablets. However, you have not qualified your suppliers as required by 21 CFR 111.75(a)(2)(ii)(A).
Your response dated June 25, 2012 does not adequately address your failure to qualify your component suppliers of dietary supplements by establishing the reliability of the certificates of analysis through confirmation of the results of the suppliers’ tests or examinations. In your response, you indicated that you were still in the initiation phase of the process of qualifying your suppliers when we inspected your firm, and you stated that you now confirm that every supplier is certified by confirming the results of the supplier’s testing. However, you did not provide any supporting documentation for FDA to evaluate the adequacy of your proposed corrective action. We also note that you must make and keep documentation of your qualification of a supplier for the purpose of relying on the supplier’s certificate of analysis, as required by 21 CFR 111.95(b)(2).
- You failed to verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength, and composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of dietary supplement, as required by 21 CFR 111.75(c). Specifically, your Cal-Mag tablets from lot #1110-311 were not assayed for dietary ingredient content, including Calcium Citrate, Magnesium Oxide, Zinc Oxide, and Vitamin D3, to determine whether specifications for strength were met prior to release. Your QA Manager and Vice President stated during the inspection that your quality control lab did not have methodology available for testing the potency of these ingredients in this product.
Your response dated June 25, 2012 states that you have implemented more effective and efficient testing of your dietary supplement products, and includes a copy of a recent batch production record of Cal-Mag tablets to indicate the effectiveness of your testing. While the corrective actions documented in your response may raise possible misbranding issues, as discussed further below, we intend to verify the sufficiency of your corrective actions with respect to 21 CFR 111.75(c) at our next inspection.
- You failed to monitor the in-process points, steps, or stages where control is necessary to ensure the quality of the finished batch of dietary supplement, to determine whether the in-process specifications are met, as required by 21 CFR 111.75(b)(1). During the inspection, our investigators inquired about your monitoring of in-process points, steps, or stages where control is necessary to ensure the quality of the finished batch of dietary supplement, to determine whether the in-process specifications are met. However, your QA Manager and Vice President stated that no such in-process testing is performed, and no in-process uniformity testing procedures are in place.
Your June 25, 2012 response states that your laboratory will perform in-process assays of products to meet specifications, that at present you are verifying product specifications by weight variation, disintegration, and friability testing, and that products are now being tested when compression or encapsulation is in progress. However, your response is inadequate in that you did not submit documentation to substantiate that you are now performing this testing.
Misbranding of Dietary Supplements:
5. Your product Raspberry Ketones is misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] and in accordance with 21 CFR 101.3(g) because the label fails to declare the term “dietary supplement” as a part of the statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product.
6. Your product Raspberry Ketones is misbranded within the meaning of 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] and in accordance with 21 CFR 101.5 because the label fails to declare the name and place of business of the manufacturer, packer, or distributor of the product.
7. Your product Raspberry Ketones is misbranded within the meaning of 403(y) of the Act [21 U.S.C. § 343(y)] because the label fails to include a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event.
This letter may not list all the violations at your facility or that exist 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 that your facility operates in compliance with the Act and applicable FDA regulations, including the CGMP regulation for dietary supplements. 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, such as seizure and/or injunction.
In addition to the violations discussed above, we have the following comment:
Your response dated June 25, 2012 states that you have implemented more effective and efficient testing of your dietary supplement products, and includes a copy of a recent batch production record of Cal-Mag tablets to indicate the effectiveness of your testing. The documentation you included with your response appears to show testing to determine whether your finished batch of the dietary supplement meets product specifications for strength, as required by 21 CFR 111.75(c). Specifically, Magnesium Oxide is an added nutrient to your Cal-Mag tablets, and the documentation you submitted with your response indicates that the Magnesium Oxide content in your Cal-Mag tablets is 98.1% of the amount declared on the label. However, we note that a product is misbranded under section 403(a) of the Act if the nutrient content of the added nutrients is not at least equal to the value for the nutrients declared on the label of the product, as required by 21 CFR 101.9(g)(4)(i).
Please respond to this letter in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations listed above and to prevent similar violations in the future. Your response should include any documentation necessary that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
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)). 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.
Please send your reply to the Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433, Attention: Kristen C. Jackson. If you have questions regarding any issues in this letter, please contact Kristen Jackson at 718-662-5711.
New York District