Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm557864.htm
Timestamp: 2019-04-20 11:08:19+00:00

Document:
From October 11 through 14, 2016, the U.S. Food and Drug Administration (FDA or we) conducted an inspection of your manufacturing facility located at 1280 W 2550 S, Ogden, UT. The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in 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 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 products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
We also advise you that FDA reviewed your website at the Internet address http://www.thorincorporated.com/ in March 2017, from which website you provide information about how to purchase your products. The claims on your website establish that your products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] 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. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Your products are not generally recognized as safe and effective for the above-referenced uses and, therefore, the products are “new drugs” under section 201(p)(1) of the Act [21 USC § 321(p)(1)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 USC §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Additionally, a drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended [21 C.F.R. § 201.5]. Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your Thor’s Fiber Drink product is intended for prevention of one or more diseases that are not amenable to prevention by consumers themselves without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, Thor’s Fiber Drink product fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
1. You failed to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of your dietary supplements and that your dietary supplements are packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70(a). Specifically, you have not established component specifications [21 CFR 111.70(b)], finished product specifications [21 CFR 111.70(e)], or labeling and packaging specifications [21 CFR 111.70(d) and 111.70(g)] for any of the dietary supplement products that you manufacture. The record you presented at the time of inspection titled “Production Specifications” does not contain a description of product or material specifications. Instead, this worksheet represents the generic batch record that is used for all operations performed on site. During our inspection, your firm’s management also stated that “Thor Inc. does not have specifications for the identity, strength, purity or composition of components used to manufacture dietary supplements. At this time specifications have not been created or approved for any materials processed on site.” Once you have established the required specifications, you must verify that the specifications are met in accordance with 21 CFR 111.73 and 21 CFR 111.75, and you must make and keep records of your specifications and the verification that they have been met in accordance with 21 CFR 111.95(b).
We reviewed your response letter, dated November 18, 2016, and are unable to evaluate the adequacy of your corrective actions. Your response states, “In establishing product specifications, we have properly maintained our (b)(4) to identify product and ensure that they are consistent with previous batches. Composition can be determined by (b)(4) and can be found in the batch manufacturing record. The strength of many products including the Liquid Vitamin E is determined (b)(4).” Your response is inadequate because the specifications you provided do not meet the above-noted general requirements relating to specifications. Specifications may include a list of test references to analytical procedures and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the tests described. Your response also did not provide evidence that you have established component specifications. We will evaluate the adequacy of your corrective actions at our next inspection.
2. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of a 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). Specifically, you do not maintain written MMRs for any of the dietary supplements processed on site. When you establish MMRs, your MMRs must include all information specified in 21 CFR 111.210.
We have reviewed your response letter, dated November 18, 2016, and are unable to evaluate the adequacy of your corrective actions. Your response states, “We have been working on putting together MBR [sic] and BMR [sic] for this job”; however, you did not provide any documentation that you have established MMRs for the dietary supplement products you manufacture. We will evaluate the adequacy of your corrective actions at our next inspection.
The results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results [21 CFR 111.260(k)(3)].
We have reviewed your response letter, dated November 18, 2016, in which you included a BPR for your Liquid Vitamin E Oil product and indicated you have updated your BPRs to include the elements required in a complete batch record. However, the documentation you provided is insufficient to demonstrate the adequacy of your corrective actions. We acknowledge your efforts to comply with requirements of 21 CFR 111.260; however, your updated BPR for your Liquid Vitamin E Oil product is inadequate because it does not contain all of the required elements, including the above-noted required elements for BPRs. We will evaluate your corrective actions with respect to BPRs at our next inspection.
4. You failed to establish and follow written procedures for how you train and qualify your employees engaged in manufacturing, packaging, labeling, or holding operations, as required by 21 CFR 111.8. Furthermore, you failed to ensure that each person engaged in manufacturing, packaging, labeling, and holding, or in performing any quality control operations, has the education, training, or experience to perform the person’s assigned functions, as required by 21 CFR 111.12(c). Specifically, you have not maintained records of employee training, and you acknowledged that you have not conducted training since before the previous FDA inspection in 2012.
We have reviewed your response letter, dated November 18, 2016, in which you indicated that you will keep more accurate training records, and we found this response to be inadequate. Your response provided four “TRAINING ATTENDANCE RECORD” sheets, but these forms do not meet all of the requirements listed in 21 CFR 111.14(b)(2). Specifically, the documents you provided are inconsistent in whether they provide complete information regarding the date and time of training and the specific type of training received; such information is required under 21 CFR 111.14(b)(2). One of the forms lists the training as “(b)(4)” This statement is overly broad and does not explain what training was received.
5. You failed to establish and follow written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and for maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.25. Specifically, you do not keep documentation of maintenance, dates of use, cleaning, and sanitization for encapsulation equipment, polishing equipment, blending equipment, or liquid and powder packaging line equipment. Furthermore, the (b)(4) used to perform all identity testing lacks records of maintenance, calibration, and usage. Additionally, when you establish and follow such written procedures, you must make and keep these records, in accordance with 21 CFR 111.35(b).
We have reviewed your response letter, dated November 18, 2016, in which you indicated that your “(b)(4) has been calibrated and maintained by (b)(4) personnel.” However, we are unable to evaluate the adequacy of your corrective actions because you failed to provide documentation to support your claim that the (b)(4) instrument has been serviced. Furthermore, your response states, “Records are now being kept of maintenance and calibration schedules”; however, you did not provide any evidence to support this corrective action. We will evaluate the adequacy of your corrective actions at our next inspection.
6. You failed to establish and follow written product complaint handling procedures, as required by 21 CFR 111.553. Specifically, you do not have written procedures for product complaints. Once you have established the required written procedures, you must make and keep a written record of every product complaint that is related to good manufacturing practice, as required by 21 CFR 111.570(b)(2), and the written record of the product complaint must comply with 21 CFR 111.570(b)(2)(ii).
The violations mentioned in this letter are not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products. It is your responsibility to ensure that all of your firm’s products comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above. Failure to promptly correct these violations may result in regulatory action by FDA without further notice, such as seizure and/or injunction.
You should respond in writing within fifteen working days of your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations noted above. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. 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 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.
Please send your written response to the U.S. Food and Drug Administration (FDA), Attention: Hanna L. Potter, Compliance Officer, P.O. Box 25087, Denver, CO 80225. If you have questions about this letter, please contact Ms. Potter at (303) 236-3094.

References: § 342
 § 321
 § 321
 § 352
 § 201
 § 353
 § 352
 § 331
 § 379
 § 379