Inspections, Compliance, Enforcement, and Criminal Investigations
Maximus Niterider International Group, Inc. 2/11/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
WL # 14-14
February 11, 2014
Mr. Wagdy M. Morcos, President
Maximus Niterider International Group, Inc.
11810 Greenstone Ave.
Santa Fe Springs, CA 90670
Dear Mr. Morcos:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement packaging and distribution facility, located at 11810 Greenstone Ave., Santa Fe Springs, California, from March 15, 2013 – April 3, 2013. The inspection revealed significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, found in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations render your Nite Rider, Nite Rider Super Size, Nite Rider Plus, Pro-Male Quick Fix, and Nite Tiger Max dietary supplement products 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 they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements.
Additionally, during the inspection our investigators collected and reviewed samples of the labeling of your dietary supplement products. Based on our review of your product labeling, we have determined that your Nite Rider, Nite Rider Super Size, Nite Rider Plus, Pro-Male Quick Fix, and Nite Tiger Max dietary supplement products are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with FDA’s labeling regulations under 21 CFR Part 101.
We acknowledge the receipt of your written response letters dated April 18, 2013 and June 26, 2013. The agency has reviewed your response letters, and we find them inadequate to address the violations listed below.
You may find the Act and the referenced regulations through links in FDA's homepage at www.fda.gov.
Dietary Supplement CGMP Violations
1. You failed to follow written quality control procedures for the responsibilities of quality control operations, including written procedures for conducting a material review and making a disposition decision and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. The quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105.
During the inspection, you informed our investigator that you provide a list of ingredients to a manufacturer with whom you contract to blend and encapsulate dietary supplements that you receive for packaging, labeling, and distribution. Your firm has established a written SOP that outlines the responsibilities of quality control, including procedures for conducting a material review and making a disposition decision and for approving or rejecting any reprocessing. However, the evidence collected from the inspection confirms that your quality control procedures have not been followed. Specifically, the following products were received from your contract manufacturer for packaging and labeling with Certificates of Analysis that were inconsistent with the finished product labels to be applied:
- Nite Rider (Lot # MXGM7501)
- Nite Rider Super Size (Lot # MXGM 7503)
- Pro-Male Quick Fix (Lot # MXGM7504)
- Nite Rider Plus (Lot # MXGM7505)
The information provided in the Certificates of Analysis did not comport with the information provided on your product labels. Therefore, the manufacture and control of the manufacturer that is blending and encapsulating dietary supplements for you are inadequate in that they are not manufacturing what you intend based on your product labels.
As a distributor that contracts with other manufacturers to manufacture 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 the products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (June 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplements into interstate commerce for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.
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 supplement it places into commerce (or causes to be placed into commerce) is 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 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 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 Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements [see 21 U.S.C. §§ 342(g) and 331(a)]. Thus, a firm that contracts out some or all of its operations 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). As noted above, you must establish and follow written procedures for the responsibilities of the quality control operations (21 CFR 111.103), and the quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations 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 111.105). 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 111.140(b)(2)).
2. You 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, as required by 21 CFR 111.205. You are required to establish and follow an MMR for the manufacturing activities that you perform (21 CFR 111.205(a)), and the MMR must identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labeled as specified in the MMR (21 CFR 111.205(b)(1)). Specifically, you informed our investigators that your firm uses a “work order” for each dietary supplement that you repackage upon receipt from your contract manufacture; however, this form is a blank template that is used for every repacking operation, regardless of product or package size. You must create a unique MMR for each dietary supplement and for each batch size that your firm repackages. The MMR must include the following for your packaging and labeling operations:
- A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)].
- Written instructions, including specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that is it packaged and labeled as specified in the MMR [21 CFR 111.210(h)(1)].
We have reviewed your response letter dated June 26, 2013, in which you state that Master Manufacturing Records have been created and that you consider the matter closed; however, we find your response inadequate because you failed to provide documentation for us to evaluate any corrective actions.
3. Your batch production records (BPR) for the packaging and labeling of your dietary supplement products failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b). For example, the BPRs for your Nite Rider Super (Lot # MXGM7503), Nite Rider (Lot # MXGM7506), and Nite Rider Plus (Lot # MXGM7505) dietary supplement products lack the following required information:
- Documentation at the time of performance of the packaging and labeling, including unique identifiers assigned to the packaging and labels used, the quantity of the packaging and labels used, reconciliation of any discrepancies between the number of labels issued and used, and either an actual or representative label used or a cross-reference to where the actual or representative label can be found. The results of any tests or examinations conducted on packaged and labeled products must also be documented [21 CFR 111.260(k)].
- Documentation at the time of performance that quality control personnel reviewed the BPR [21 CFR 111.260(l)].
We have reviewed your response letters dated April 8 and June 26, 2013 and find them to be inadequate. Your response states that a physical location has been designated for the representative label and that the batch records will be revised to identify that location within two months. You also stated that training has been given. However, you did not include evidence of the location designated for the representative label or any evidence of training quality personnel on the review and approval (or rejection) of batch production records, nor have you provided documentation of training activities. In addition, you did not include a copy of the updated BPR.
Misbranded Dietary Supplements
Your Nite Rider, Nite Rider Super Size, Nite Rider Plus, Nite Tiger Max, and Pro-Male Quick Fix dietary supplement products are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with FDA’s labeling regulations under 21 CFR Part 101.
1. Your Nite Rider, Nite Rider Super Size, Nite Rider Plus, Nite Tiger Max, and Pro-Male Quick Fix dietary supplement products are misbranded within the meaning of section 403(e) of the Act in that your product labels fail to declare the place of business of the manufacturer, packer or distributor in accordance with 21 CFR 101.5.
2. Your Nite Rider, Nite Rider Super Size, Nite Rider Plus, Nite Tiger Max, and Pro-Male Quick Fix dietary supplement products are misbranded within the meaning of section 403(y) of the Act in that the product 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 supplement.
3. Your Nite Rider, Nite Rider Super Size, and Nite Rider Plus dietary supplement products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that your Supplement Facts panel does not comply with 21 CFR 101.36 and 101.4(g). Specifically, the ingredient statements for the products must be declared outside of the Supplement Facts panel. In addition your listing of “Inactive Ingredients” is not declared appropriately; the term “Inactive” is not permitted under 21 CFR 101.4(g).
4. Your Nite Rider, Nite Rider Super Size, Nite Rider Plus, Nite Tiger Max, and Pro-Male Quick Fix dietary supplement products are misbranded within the meaning of section 403(s)(2)(C) of the Act because the product labels fail to identify the parts of the plants from which the ingredients are derived in accordance with 21 CFR 101.4(h).
The above violations are not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and all applicable regulations.
You should take prompt action to correct the violations cited in this letter and prevent their recurrence. Failure to implement lasting corrective actions may result in legal action being initiated by FDA without further notice, such as seizure and/or injunction.
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations and to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long-term, corrective actions. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay, and please include a timetable for the implementation of any remaining 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 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)). 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 send your reply to the Food and Drug Administration, Attention:
Blake Bevill, Director
Los Angeles District
Irvine, CA, 92612-2506
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at (619)-941-3769.
Alonza E. Cruse, Director
Los Angeles District
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence