Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm462745.htm
Timestamp: 2019-04-24 10:24:58+00:00

Document:
On November 14 through November 17, 2014, the U.S. Food and Drug Administration (FDA) performed an inspection of your manufacturing facility located at 1206 W. Main St., Atkins, Arkansas 72823. 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 current good manufacturing practice regulations for dietary supplements found under 21 CFR Part 111. Additionally, we have reviewed your product labels collected during the inspection and we 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.
During the inspection, our investigators were informed that your firm has entered into agreements with various manufacturers who manufacture dietary supplement products that your firm packages, labels, holds, and/or distributes. Further, our investigators were informed that your firm is ultimately responsible for marketing and distributing your finished dietary supplement products. 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) 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 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) 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.
As a distributor, you have 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. 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 failed to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to 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 111.55.
Specifically, your firm receives dietary supplements from manufacturers that you then package, label, and/or hold prior to distribution. Your firm packages, labels, and holds Equalizer AM, Glutamean, and Chain Gang under your firm’s brand name Chaotic Labz. At the time of inspection, you stated that you do not have a system of production and process controls in place to cover stages of packaging, labeling, and holding of dietary supplements.
You failed to establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications). Packaging that may come into contact with dietary supplements must be safe and suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement, as required by 21 CFR 111.70(d). During our inspection, you stated that your firm does not have any dietary supplement label or packaging specifications. We further note that you are required to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you use the specified packaging and that you apply the specified label, as required by 21 CFR 111.70(g).
You did not prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Packaging and labeling are considered manufacturing operations; therefore, you must prepare and follow a written MMR that covers the packaging and labeling operations of your firm. Specifically, you informed our investigators that your firm had not prepared written MMRs for any of the dietary supplement products it manufactures, to include Equalizer AM, Creamean, Glutamean, Malice, Annihilation, Hypnotic, Malice in Wonderland and Inception. We note that an MMR must include the information specified in 21 CFR 111.210.
You failed to establish and follow written procedures for the responsibilities of the quality control operations, as required by 21 CFR 111.103. During our inspection, you informed our investigators that you do not have any written procedures for quality control operations. We note that 21 CFR 111.105 outlines operations that quality control personnel must perform to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. Along with establishing your procedures for the responsibilities of quality control operations, you must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to 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 111.65.
You failed to visually examine the supplier’s invoice, guarantee, or certification in a shipment of received product to ensure that the received product is consistent with your purchase order, as required by 21 CFR 111.165(b). Specifically, your product "Mayhem" was voluntarily recalled during our inspection for containing the undeclared drug ingredients cyproheptadine and dexamethasone. During our inspection, you informed our investigators that no review or examination of the supplier’s invoice, guarantee, or certification was made for "Mayhem" product received from your supplier.
You failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403. Specifically, at the time of inspection your firm was not able to provide written procedures for packaging and labeling operations for your Equalizer AM, Creamean, Glutamean, Malice, Annihilation, Hypnotic, Malice in Wonderland and Inception products. We note that repackaging and relabeling also are subject to the requirements of 21 CFR 111.420.
You failed to establish and follow written procedures for the requirements for product received for packaging or labeling as a dietary supplement, as required by 21 CFR 111.153. Specifically, your firm receives dietary supplements from manufacturers, but your firm has not established any written procedures for receiving your dietary supplement products Equalizer AM, Creamean, Glutamean, Malice, Annihilation, Hypnotic, Malice in Wonderland, or Inception. You also told our investigators at the time of inspection that your firm has not established a written procedure for receiving dietary supplement products. We note that requirements applicable to a product received for packaging or labeling and distribution as a dietary supplement may be found at 21 CFR 111.165.
You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, during the inspection you were unable to provide written procedures for holding your dietary supplement products, including Glutamean, Equalizer, and Chain Gang, and you stated that you do not have written procedures for holding and distributing operations.
Your firm did not collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, to include Glutamean, Equalizer, and Chain Gang, as required by 21 CFR 111.83(a). During the inspection, you confirmed that your firm did not collect and hold reserve samples of your dietary supplements. We note that, for each lot of packaged and labeled dietary supplements that you distribute, the reserve sample you collect must meet the requirements of 21 CFR 111.83(b); namely, the reserve samples must: (1) be held in the same container-closure system in which the packaged and labeled dietary supplements were distributed; (2) be identified with the appropriate batch, lot, or control number; (3) be retained for one year past the shelf life date (if shelf life dating is used), or for two years from the date of distribution of the last batch of dietary supplements associated with a reserve sample; and (4) consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications.
You failed to establish and follow written procedures for product complaints, as required by 21 CFR 111.553 and in accordance with 21 CFR 111.560. Specifically, your firm has no written procedures for reviewing and investigating product complaints, as you acknowledged during our investigation.
You failed to establish and follow written procedures for cleaning the physical plant and for pest control, as required by 21 CFR 111.16. A physical plant is all or any part of a building or facility used for manufacturing, packaging, labeling, or holding dietary supplements. See 21 CFR 111.3. Your firm stores finished retail-size packages of dietary supplements in the firm’s warehouse. Your firm also has (b)(4) rooms used to package and label samples of its dietary supplement products. However, at the time of inspection, you told to our investigators that you have not established written procedures for cleaning the physical plant and for pest control.
We received a response from you (undated) concerning our Investigators’ observations noted on the FDA 483. We acknowledged receipt of your written response to the FDA 483, received December 09, 2014. The response was deemed inadequate because it does not address any of the 19 observations listed on the FDA 483. In the response letter you promised to send monthly status reports, beginning the first week of January 2015. Thus far, no subsequent responses to the FDA 483 have been received.
Your Equalizer AM, Creamean, Glutamean, Malice, Annihilation, Hypnotic, Malice in Wonderland and Inception products are misbranded within the meaning of section 403(e)(1) of the FD&C Act [21 U.S.C. § 343(e)(1)] in that the labels fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
Your Malice in Wonderland product is misbranded within the meaning of section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)] in that the label fails 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) and 21 CFR 101.36(d)(1). For example, your Malice in Wonderland product label fails to include the part of the plant from which Hoodia, Green Tea extract, Yohimbe, Ephedra Extract and Citrus Aurantium are derived.
Your Equalizer AM, Creamean, Glutamean, Malice, Annihilation, Hypnotic, Malice in Wonderland and Inception 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.
This letter is not an all-inclusive list of violations at your facility. 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.
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 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 FD&C 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)).
For a domestic facility, 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 FD&C Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please submit your response to John W. Diehl, Compliance Officer, at the above letterhead address. If you have any questions please contact Mr. Diehl at 214-253-5288.
Mr. Phillip Fruechting, R. S.

References: § 342
 § 343
 v. 
 v. 
 § 343
 § 343
 § 343
 § 379
 § 379