Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm428803.htm
Timestamp: 2019-04-21 22:48:47+00:00

Document:
The U.S. Food and Drug Administration (FDA) conducted inspections at your dietary supplement manufacturers, Nutri Spec, Inc. located at 89 Swamp Road, Mifflintown, PA from April 7, 2014 to April 24, 2014 (Mifflintown facility); and at Nutri Spec Testing, located at 4729 Lucerne Road, Indiana, PA on March 26, 2014 to April 23, 2014 (Indiana facility). Our inspections found that both of these facilities have serious violations of the Current Good Manufacturing Practice (cGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR 111). These violations cause your dietary supplement products identified below to be adulterated within the meaning of 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.
Additionally, we have reviewed your product labels collected at the inspection and we have determined that they are in violation of sections 403 of the Act [21 U.S.C. § 343] and the regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
During the inspection, you were not able to provide any specifications for the points, steps, or stages in the manufacturing process where controls would be necessary to ensure the quality of the finished product, as required by 21 CFR 111.70. Such specifications, as part of a system of production and process controls, are needed to ensure the quality of the dietary supplements you manufacture and that they are packed and labeled as specified in the MMR.
Your BPR must include the identity of the equipment and processing lines used in producing the batch [21 CFR 111.260(b)].
Your BPR must include the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained [21 CFR 111.260(c)].
Your BPR must include the identity and weight or measure of each component used [21 CFR 111.260(e)].
Your BPR must include a statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)].
Your BPR must include documentation that the finished dietary supplement meets specifications established in accordance with § 111.70(e) and (g) [21 CFR 111.260(i)].
Your BPR must include documentation, at the time of performance, of the manufacture of the batch, including the date on which each step of the master manufacturing record was performed and the initials of the person responsible for weighing or measuring each component used in the batch, the initials of the person responsible for verifying the weight or measure of each component used in the batch, the initials of the person responsible for adding the component to the batch, and the initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)].
Your BPR must include documentation, at the time of performance, of packaging and labeling operations including the unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels; an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR; and 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)].
Your BPR must include documentation at the time of performance that quality control personnel reviewed the BPR; approved or rejected any reprocessing or repackaging; approved and released, or rejected, the batch for distribution, including any reprocessed batch; and approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement [21 CFR 111.260(l)].
3. You failed to implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing your dietary supplements to ensure the quality of your dietary supplements, and that the dietary supplements are packaged and labeled as specified in the master manufacturing records, as required by 21 CFR 111.65.
During the inspection, you were unable to provide any documentation when requested by our investigator that you implemented quality control operations.
4. Your firm failed to prepare and follow a written MMR for each batch size of dietary supplement that you manufacture, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). For example, you are manufacturing Nutri Spec brand Sodium Citrate 2 oz.; Magnesium Chloride 2 oz.; Potassium Citrate 2 oz.; Di-Potassium Phosphate 2 oz.; Potassium Bicarbonate 2 oz.; Sodium Glycerophosphate 1.6 oz.; and A Good Thyme 2 fl. oz. products without written MMRs.
5. You failed to establish written procedures for manufacturing operations, as required by 21 CFR 111.353 and to make and keep records of these written procedures, as required by 21 CFR 111.375. The requirements for manufacturing operations are specified in 21 CFR 111.355, 111.360, 111.365, and 111.370.
During the inspection, you were unable to provide any documentation when requested by our investigator that you established written procedures for manufacturing operations.
6. You failed to establish and follow written procedures for your packaging and labeling operations, as required by 21 CFR 111.403 and 21 CFR 111.430(b).
During the inspection, you were unable to provide any documentation when requested by our investigator that you had established, followed, and maintained written procedures for your packaging and labeling operations.
7. You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a).
During the inspection, you were unable to provide any documentation when requested by our investigator that you collect and hold reserve samples of each lot of packaged and labeled dietary supplement product that you distribute.
8. Your firm failed to establish written procedures to fulfill the requirements related to product complaints as required by 21 CFR 111.553, and for the review and investigation of product complaints, as required by 21 CFR 111.560. Further, you did not make and keep written procedures for the review and investigation of product complaints, as required by 21 CFR 111.570(b)(1).
During the inspection, you were unable to provide any documentation when requested by our investigator that you established written procedures to fulfill the requirements related to product complaints.
1. Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use in the Oxygenic A-Plus product, as required by 21 CFR 111.75(a)(1)(i). Specifically, when our investigator asked about the magnesium thiosulfate hexahydrate ingredient in the product, your employee stated that no testing or examination was performed on this ingredient.
2. You must implement 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 a master manufacturing record (MMR), as required by 21 CFR 111.55. Specifically, you do not have a system of production and process controls to ensure the quality of your Nutri Spec brand Electro Tonic (32 fl.oz.); Oxygenic A-Plus (2 fl.oz. and 4 fl. oz.); Oxygenic D-Plus (2 fl. oz.) and Phos Drops (2 fl. oz.) products.
During the inspection, your employee was unable to provide any specifications for the points, steps, or stages in the manufacturing process where controls would be necessary to ensure the quality of the finished product, as required by 21 CFR 111.70.
3. You failed to prepare a batch production record, as required by 21 CFR 111.255 and 111.260. You must prepare a batch production record (BPR) every time you manufacture a batch of a dietary supplements, as required by 21 CFR 111 255(a). Specifically, you did not prepare BPRs every time you manufactured a batch of Nutri Spec brand Electro Tonic (32 fl.oz.); Oxygenic A-Plus (2 fl.oz. and 4 fl. oz.); Oxygenic D-Plus (2 fl. oz.) and Phos Drops (2 fl. oz.) products.
During the inspection, your employee indicated that she did not prepare a batch production record for any batches of the products she manufactured.
4. 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, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1).
During the inspection, your employee indicated to our investigator that no written procedures exist at your facility for the responsibilities of the quality control operations.
During the inspection, your employee was unable to provide any documentation when requested by our investigator that you established written procedures for manufacturing operations.
During the inspection, your employee was unable to provide any documentation when requested by our investigator that you established written procedures for packaging and labeling operations.
During the inspection at your Mifflintown facility, you informed our investigator that Nutri Spec, Inc. will be (b)(4). You stated that Nutri Spec, Inc. will be (b)(4). You also stated that Nutri Spec, Inc. will distribute the dietary supplement products that are (b)(4), under the Nutri Spec, Inc. label.
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 would have an obligation to know what and how manufacturing 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)]. As a distributor, your firm would be introducing or delivering, or causing the introduction or delivery, of the dietary supplement into interstate commerce in its final form for distribution to consumers. As such, your firm would have 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 contract’s 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.
The product “A Good Thyme” dietary supplement failed to bear nutrition labeling in the form of a “Supplement Facts” label as required by 21 CFR 101.36.
The “Supplement Facts” panel on your Oxygenic A-Plus 2 oz. and 4 oz. dietary supplement product labels are not formatted in accordance with 21 CFR 101.36(b)(3)(i) because they do not separate dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) and dietary ingredients for which RDIs and DRVs have not been established with a heavy bar as required by 21 CFR 101.36(e)(6).
Further, the Nutri Spec Oxygenic A-Plus and Nutri Spec Magnesium Chloride products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C § 343(q)(5)(F)] because the source ingredients that supplies the dietary ingredients magnesium and sulfur were not identified within the Supplement Facts box in accordance with 101.36(d). Since the source ingredient of these two dietary ingredients was not listed in an ingredient statement in accordance with 21 CFRR 101.4(g), your product is misbranded accordingly.
Your “A Good Thyme” product is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. 403(s)(2)(B)] because the label fails to identify the product using the term “dietary supplement,” as required by 21 CFR 101.3(g).
With regard to the magnesium thiosulfate hexahyrate that you use in some of your dietary supplement products, including Oxygenic A-Plus, please provide evidence that this ingredient has been used as a dietary ingredient in a dietary supplement before October 15, 1994. If an ingredient is not found to be used and marketed before this date, you are subject to the new dietary ingredient (NDI) requirements found in section 413(a) of the Act [21 U.S.C. 350b(a)]. Under section 413 of the Act [21 U.S.C. 350b(a)] a dietary supplement is adulterated under 402(f) unless it meets one of two requirements, (1) the dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or (2) there is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe (see implementing regulations in 21 CFR 190.6).
During the inspection, our investigator was informed by two of your part time employees that they were not familiar with the dietary supplement cGMP requirements or its regulation. Under 21 CFR 111.12(c), personnel engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must have the education, training, or experience to perform their assigned functions.
Your response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Bonner can be reached at 215-717-3074 or Lynn.Bonner@fda.hhs.gov.

References: § 342
 § 343
 § 111
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 § 343