- Nutraloid Labs Inc
- Issuing Office:
- New York District Office
| || |
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
January 8, 2016
WARNING LETTER NYK-2016-19
Mr. Bartholmew A. Panessa, Owner
Nutraloid Labs Inc.
120 Wood Road, Building #2
Kingston, NY 12401-1112
Dear Mr. Panessa:
On June 23, July 9, September 10, and October 7, 2015, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement facility located at 120 Wood Road, Building #2, Kingston, New York. Our inspection revealed a number of significant violations of 21 CFR Part 111, Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. 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 FD&C Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed or held under conditions that do not meet the CGMP regulations for dietary supplements found under 21 CFR Part 111. Additionally, we have reviewed your product labels collected during the inspection and have determined that your products identified below are in violation of section 403 of the FD&C Act [21 U.S.C. § 343] and/or the regulations implementing the food labeling requirements of the FD&C Act, which are found in 21 CFR Part 101. You may find the FD&C Act and the Code of Federal Regulations (CFR) through links on FDA’s home page at www.fda.gov
Adulterated Dietary Supplements
Your significant CGMP violations noted during our most recent inspections are as follows:
1. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). Your quality control personnel must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution. See 21 CFR 111.127. You have no written procedures for quality control operations; you do not perform any quality control operations for the products you distribute into interstate commerce; you do not review the quality control practices of your contract manufacturers; you do not have a quality agreement with your contract manufacturers outlining responsibilities; and you do not review or sign off for finished product release prior to distribution.
As a distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how these activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery of, dietary supplements into interstate commerce in their final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of those products are in compliance with dietary supplement CGMP requirements found under 21 CFR Part 111.
Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplements it places into commerce (or causes to be placed into commerce) are not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the FD&C Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the FD&C Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act)). In particular, the FD&C Act prohibits a person from introducing, delivering for introduction, or causing the delivery or introduction into interstate commerce of a dietary supplement that is adulterated under section 402(g) of the FD&C Act for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. §§ 342(g) and 331(a)). Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.
You must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). You must establish and follow written responsibilities of the quality control operations (21 CFR 111.103 and 21 CFR 111.105). Further, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 21 CFR 111.140(b)(2)). However, you have provided no documentation of the quality control review to ensure the quality of the dietary supplements you distribute and that they are packaged and labeled according to the master manufacturing record.
2. You failed to make and keep documentation of training, including the date of the training, the type of training, and the person(s) trained, as required by 21 CFR 111.14(b)(2). Specifically, you do not have any records related to employee training.
3. You failed to establish and follow written procedures for cleaning the physical plant and for pest control, as required by 21 CFR 111.16. Specifically, you have not established written procedures for cleaning the physical plant and for pest control.
4. You failed to establish and follow written procedures for returned dietary supplements, as required by 21 CFR 111.503. Specifically, you have not established written procedures for returned dietary supplements.
5. Your firm failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, your firm has not established written procedures for the handling of product complaints regarding the dietary supplement products you distribute. In addition to establishing such written procedures, you must maintain a written record of every product complaint that is related to good manufacturing practice, as required by 21 CFR 111.570(b)(2). You have received complaints regarding the products you distribute; however, you have no procedure in place for documenting such complaints or the findings of any investigation or follow-up action when such activities are performed.
6. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you receive packaged and labeled dietary supplements from your contract manufacturers for distribution to customers, but you do not have any written procedures for your holding and distribution operations.
Misbranded Dietary Supplements
1. Your Humoloid-HGH, Tribuloid Testosterone Boost and Groloid products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event associated with such dietary supplement.
2. Your “Humoloid-HGH” and “Tribuloid Testosterone Boost” products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] )] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). For example:
- Your “Humoloid-HGH” product label fails to include the part of the plant from which “Long Jack” is derived.
- Your “Tribuloid Testosterone Boost” product label fails to include the part of the plants from which “Epimedium sagittatum,” “Xanthoparmelia Scabrosa,” and “Long Jack” are derived.
3. Your “Humoloid-HGH” product is misbranded within the meaning of section 403(q)(1)(A) because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions of use suggest the consumer take two 2 to 3 sprays at bedtime, but the serving size lists 6 sprays. The serving size listed should be 3 sprays.
This letter is not an all-inclusive list of violations at your facility or in connection with your products. It is your responsibility to ensure that your products comply with the FD&C Act and FDA’s implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice, including, without limitation, seizure or injunction.
Additionally, we have the following comment. Because your firm receives and approves labeling and then supplies the labeling to your contract labelers, you must comply with the requirements of 21 CFR 111.160 for packaging and labels received.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations as well as any supporting documentation. 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 FD&C 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 FD&C 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 FD&C Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: LCDR Catherine Beer, Compliance Officer, One Winners Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contactLCDR Catherine Beerat 518-453-2314 x1015.
New York District