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Dallas District Office
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204
February 3, 2017
Robert Reynolds, President & CEO
ProSupps USA LLC
2801 East Plano Parkway
Plano, Texas 75074
Dear Mr. Reynolds:
The United States Food and Drug Administration (FDA) conducted an inspection of the dietary supplement distribution facility, ProSupps USA LLC, located at 2801 East Plano Parkway, Plano, Texas, from February 5 through March 14, 2016. During the inspection, our investigator identified significant violations of the Current Good Manufacturing Practice (cGMP) regulations for dietary supplements, which are set out 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)] in that the dietary supplements have been prepared, packed, or held under conditions that do not meet cGMP requirements for dietary supplements. Additionally, ProSupps USA LLC failed to submit Serious Adverse Event Reports, as required by section 761(c) of the Act [21 U.S.C. §§ 379aa-1(c)].
You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov
Adulterated Dietary Supplements
Significant cGMP violations noted during our inspection are as follows:
1. We observed a failure to follow written procedures for the review and investigation of product complaints, as required by 21 CFR 111.553, and a failure to conduct product complaint reviews and investigations, as required by 21 CFR 111.560(a). For example:
a. A complaint was received on August 4, 2015, for Mr. Hyde Blue Razz dietary supplement that resulted in the hospitalization of the consumer. According to our Investigator, this complaint was not reviewed or investigated.
b. A complaint was received on March 24, 2015, for Mr. Hyde Blue Razz dietary supplement, where the consumer complained the product prevented her from sleeping and caused difficulty breathing. The investigation for this product, which did not conclude until June 3, 2015, included only a review of the certificate of analysis of this lot of product, rather than an investigation, as required by 21 CFR 111.560(a).
2. We observed a failure 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).
To the extent you contract 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 manufacturing activities are performed so that your firm can make decisions related to whether your packaged and labeled dietary supplement products conform to established specifications and whether to approve and release the products for distribution [See 72 Fed. Reg. 34752, 34790 (June 25, 2007)].
Further, to the extent that your firm introduces or delivers, or causes the introduction or delivery, of dietary supplements into interstate commerce for distribution to consumers, 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. At the time of the inspection, dietary supplements manufactured at the facility were also manufactured by several contract manufacturers. Even if your firm contracts out certain dietary supplement manufacturing operations, it cannot 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 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 must establish a system of production and process controls to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). 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).
Your firm’s quality control personnel must approve for release or reject any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.127(h) and 21 CFR 111.140(b). During the inspection, FDA was provided with no written procedures for, or documentation of, the approval for release of the dietary supplements by quality control personnel.
Further, during the inspection there was no documentation of quality control review and approval of labels, as required by 21 CFR 111.127(d) and 21 CFR 111.140(b). Specifically, we observed the failure of quality control personnel to reject, approve a treatment, approve an in-process adjustment, or approve dietary supplements that did not meet specifications established under 21 CFR 111.70(g), as required by 21 CFR 111.77(a). During our inspection, we noted that more than (b)(4) of Dr. Jekyll Watermelon V2 dietary supplements received from a contract manufacturer did not have the correct finished product label, but quality control personnel accepted this product that did not meet finished product label specifications.
3. We observed a failure to establish specifications for the labeling of the dietary supplements that you distribute, as required by 21 CFR 111.70(d). Specifically, during the inspection it was noted that although ProSupps USA LLC is responsible for finished product labels, there was no documentation of label specifications.
4. We observed a failure to establish and follow written procedures for fulfilling the requirements for returned dietary supplements, as required by 21 CFR 111.503.
For example, during the inspection, our Investigator noted that ProSupps USA LLC received approximately (b)(4) units of returned Mr. Hyde and Dr. Jekyll dietary supplements, but that there were no written procedures for how to receive returned dietary supplements, as required under 21 CFR 111.510. Further, for the mislabeled products, we noted a failure to conduct an investigation to determine the underlying cause of the mislabeling, and to determine whether contract manufacturers incorrectly labeled additional lots or products, as required by 21 CFR 111.530.
Failure to Submit a Serious Adverse Event Report
A Serious Adverse Event Report (SAER) for a dietary supplement was not submitted as required by section 761(c) of the Act [21 U.S.C. §§ 379aa-1(c)]. For example:
a. ProSupps USA LLC received a complaint on August 4, 2015, for Mr. Hyde Blue Razz dietary supplement, that resulted in the hospitalization of the consumer. An SAER was filed with the FDA, but not until February 24, 2016.
b. ProSupps USA LLC received a complaint on March 24, 2015, for Mr. Hyde Blue Razz dietary supplement, in which the consumer complained the product prevented her from sleeping, and caused difficulty breathing. An SAER was not filed with the FDA for this complaint.
Under section 761(c) of the Act, you must submit a report of a serious adverse event associated with any of your dietary supplements no later fifteen (15) business days after a report of the event is received through the address or phone number provided on your dietary supplement products. Because prompt submission of such serious adverse event reports is important for public health reasons, the agency recommends that all serious adverse events be reported to FDA within fifteen (15) business days of receipt regardless of the means by which you receive the initial report. These serious adverse event reports must be submitted under the MedWatch Form 3500A. More information on adverse event reporting can be found on FDA’s website at www.fda.gov
, in the publication “Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection.”
This letter is not intended to be an all-inclusive list of violations that may exist at your facility, or in connection with your products or 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. You are responsible for ensuring that your firm operates in compliance with the Act and applicable FDA regulations, including dietary supplement cGMP regulations (21 CFR Part 111). You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction.
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 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. 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.
You should respond in writing within fifteen (15) business 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 cannot complete all the corrective actions within fifteen (15) working days, we expect that you will explain the reason for your delay and state the time within which you will complete the corrections.
Your written response should be sent to Jamie M. Bumpas, Compliance Officer, U. S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas, 75204. If you have any questions regarding any issues in the letter, please contact Ms. Bumpas at 214-253-5336.
Gerald D. Bromley, Jr.
Acting Dallas District Director
Texas Department of State Health Services
Mr. Greg Wilburn
Inspection Unit Manager
Food And Drug Inspections Branch
1100 West 49th Street
Austin, Texas 78756