Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm555226.htm
Timestamp: 2019-01-18 18:47:56
Document Index: 239785060

Matched Legal Cases: ['art 111', 'art 111', '§ 342', '§ 343', 'art 101', '§ 343', '§ 343', '§ 343']

Naturecom Inc. 4/20/17
WL # 26-17
Xiuli (Erin) Zhang, CEO
From November 2 through November 10, 2016, the U.S. Food and Drug Administration (FDA or we) inspected your facility located at 8 Rancho Circle, Lake Forest, CA 92630. Based on our inspection and subsequent review of your product labeling collected during the inspection, we identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable FDA regulations. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.
Our inspection of your facility revealed that you failed to comply with the Current Good Manufacturing Practice (CMGP) regulations for dietary supplements, found in Title 21 of the 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 Act [21 U.S.C. § 342(g)(1)], in that they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.
1. You failed to prepare and follow a master manufacturing record (MMR) for the dietary supplement products that you package and label, as required by 21 CFR 111.205(a). Specifically, you do not have any MMRs for the dietary supplement products that you package and label. A master manufacturing record for a firm that only packages and labels the dietary supplement must include specifications that are applicable to its operations [see 72 Fed. Reg. 34752, 34902 (June 25, 2007)].
Once you establish an MMR for the dietary supplement products that you package and label, you must establish specifications to 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 111.70(a)), and you must fill, assemble, package, label, and perform other related operations in a way that ensures the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.415). Additionally, to the extent you receive a product from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), you must establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order (21 CFR 111.70(f)).
We have reviewed your December 18, 2016, response; however, we are unable to evaluate the adequacy of your corrective action. Your response states that you have established MMRs for each batch size of a dietary supplement that you manufacture. However, the MMRs provided in your response failed to include actual or representative labels associated with them (see 21 CFR 111.210(g)).
2. Your batch production records (BPRs) failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, your batch production records do not include the following:
a. The identity of equipment used in producing the batch, such as the scales, scoops, and package sealing equipment.
b. The date and time of maintenance, cleaning, and sanitization 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.
c. The weight or measure of each finished package.
d. The date and time of when weighing and packaging occurred.
e. The quantity of packaging materials and labels used.
f. An actual or representative label or cross-reference to the physical location of the actual or representative label specified in the master manufacturing record.
g. The issuance and use of packaging materials and labels and reconciliation of any issuance and use discrepancies.
We have reviewed your December 18, 2016, response; however, we are unable to evaluate the adequacy of your corrective action. It is unclear how the generic template you provided with your response will apply to a specific dietary supplement products or specific batches of dietary supplement product, as required. Additionally, the supporting documentation you provided with your response fails to include the following information required by 21 CFR 111.260:
The statement of actual yield and statement of the percentage of theoretical yield must be included at appropriate phases of processing in accordance with CFR 111.260(f);
The actual results obtained during the monitoring operations described in steps 3 through 6 of the document you provided, in accordance with 21 CFR 111.260(g);
The results of any tests or examinations conducted on packaged and labeled dietary supplements, such as those described in steps 6.1, 6.3, 7, and 8 of the document you provided, in accordance with 21 CFR 111.260(k)(3);
Documentation at the time of performance that quality control personnel reviewed the results of any tests and examinations, including those for packaged and labeled dietary supplements, such as those described in step 3 of the document you provided, in accordance with 21 CFR 111.260(l)(1)(ii)
Your products are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with FDA’s labeling requirements under 21 CFR Part 101.
1. Your NVS Labs Caffeine Tablets and NVS Labs Beta Alanin products are misbranded within the meaning of section 403(y) of the 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 (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
2. Your NVS Labs Caffeine Tablets, NVS Labs Instantized BCAA, and NutriVita Shop Methylsulfonylmethane products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] in that the product labels fail to bear nutrition labeling in the form of a “Supplements Facts” label, as required by 21 CFR 101.36.
3. Your NVS Labs Caffeine Tablets product is misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because the product label fails to identify the product using the term “dietary supplement,” as required by 21 CFR 101.3(g).
Additionally, we have the following comment. We acknowledge that you have voluntarily recalled your products containing 1,3-dimethylamylamine, also known as DMAA or geranium extract. Please provide this office with the status of your activities of this on-going recall and any action plan you have to prevent this from reoccurring.
Kelly D. Sheppard, Director, Compliance Branch
If you have any questions please contact Dr. Raymond W. Brullo, Compliance Officer, at (949) 608-2918.