Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm407054.htm
Timestamp: 2019-04-22 06:12:14+00:00

Document:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, Mezotrace Corporation, located at 415 Wellington Street, Winnemucca, Nevada, on August 19 and 20, 2013. During our inspection, you informed our investigator that your firm holds and distributes dietary supplements for which you have entered into agreements with contract manufacturers to manufacture, package, and label under your firm’s name. You also informed our investigator that your firm provides the main raw ingredient (magnesium limestone mineral) to the contract manufacturers for the production of your dietary supplements products. Based on our inspection, we found serious violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your Mezotrace Calcium/Magnesium Natural Minerals & Trace Elements, Mezotrace Calcium/Magnesium Natural Minerals & Trace Elements with Vitamin D, and Mezotrace Calcium/Magnesium Powdered Minerals Natural Minerals & Trace Elements 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 supplement products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Our investigator’s observations were noted on form FDA-483, Inspectional Observations, which was issued to you on August 20, 2013.
In addition, FDA reviewed your product labeling and your website at the Internet address www.mezotrace.com in October 2013, and again in June 2014, and has determined that your MEZOTRACE® products are being promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your websites and in your product labeling establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
We received your written response letters, dated September 3, 2013, and September 25, 2013; we have reviewed your responses, and we address your proposed corrective actions below.
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, your MEZOTRACE® products are new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your MEZOTRACE® products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
Even if your MEZOTRACE® Calcium/Magnesium Natural Minerals & Trace Elements, Calcium/Magnesium Natural Minerals & Trace Elements with Vitamin D, and Calcium/Magnesium Powdered Natural Minerals & Trace Elements dietary suplements did not have therapeutic claims which make them unapproved new and misbranded drugs, these products are adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements.
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 with other firms to conduct dietary supplement manufacturing, packaging, and labeling operations is ultimately responsible for ensuring that the product complies with the dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.
1. You failed to implement quality control operations in your holding operations to ensure the quality of your dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing records, as required by 21 CFR 111.65. During the inspection, you informed our investigator that you do not have any quality control operation procedures to ensure the quality and contents of the finished dietary supplement products you receive from your contract manufacturers, and that you distribute your dietary supplement products without ensuring their quality.
We received your written response dated September 25, 2013, in which you included a document titled, “(b)(4),” stating that “(b)(4),” all quality control procedures. However, you did not include any documentation to demonstrate that you are implementing quality control operations in your operations for your dietary supplement products. We are therefore unable to verify the adequacy of your proposed corrective action.
2. 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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). You informed our investigator that your firm does not have any written procedures regarding quality control operations. Your firm’s quality control personnel must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by 21 CFR 111.127(h). During the inspection, you also informed our investigator that you do not have any personnel specifically responsible for quality control operations. You must identify personnel who is responsible for your quality control operations, as required by 21 CFR 111.12(b).
We received your written response dated September 25, 2013, with which you have submitted a document entitled “(b)(4).” However, this document inadequately addresses the violations because it does not establish 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. We also note that the procedures listed in this document are identical to the written procedures in the document entitled “(b)(4),” which you also submitted with your written response. We note that each person who is identified to perform quality control operations must have distinct and separate responsibilities related to performing such operations from those responsibilities that the person otherwise has when not performing such operations, as required by 21 CFR 111.12(b).
3. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. During the inspection, you informed our investigator that you have not established written procedures for holding and distributing dietary supplement products.
We received your written response dated September 25, 2013, in which you submitted a document entitled “(b)(4)”; however, your response is inadequate because the document does not adequately meet the requirements of 21 CFR Subpart M – Holding and Distributing. For example, the document does not adequately address how your firm will meet the requirements related to holding reserve samples of your dietary supplement products in accordance with 21 CFR 111.465.
4. You failed to establish and follow written procedures for returned dietary supplements, as required by 21 CFR 111.503. During the inspection, you informed our investigator that you do not currently have written procedures for returned dietary supplements.
We received your written response dated September 25, 2013, in which you submitted a document entitled “(b)(4)”; however, your response is inadequate because the document is a template to record returned dietary supplements, but fails to meet the requirement under 21 CFR 111.503 to establish and follow written procedures for returned dietary supplements.
5. You failed to establish and follow written procedures for product complaints, as required by 21 CFR 111.553. During the inspection, you informed our investigator that your firm has not established written procedures for the review and investigation of product complaints.
We received your written response dated September 25, 2013, in which you submitted a document entitled “(b)(4)”; however, your response is inadequate because the document is a template to record product complaints, but fails to meet the requirement under 21 CFR 111.553 to establish and follow written procedures for product complaints.
The violations described above are not meant to be an all-inclusive list of 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 firm complies with the Act and applicable FDA regulations. 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, including, without limitation, seizure and injunction under sections 302 and 304 of the Act [21 U.S.C. §§ 332 and 334].
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)]. 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 Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations cited in this letter. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction.
Please send your reply to the U. S. Food and Drug Administration, Attention: Lawton W. Lum, Director of Compliance, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. Please reference the CMS number 412687 in your response.
If you have questions regarding any issues in this letter, please contact Compliance Officer Erlinda Figueroa at (510) 337-6795.

References: § 342
 § 321
 § 321
 § 355
 § 331
 § 352
 § 331
 § 342
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