WARNING LETTER
Naturecom Inc. MARCS-CMS 512786 —
- Recipient:
- Naturecom Inc.
United States
- Issuing Office:
- Los Angeles District Office
United States
| |
Los Angeles District 19701 Fairchild, Irvine CA 92612-2506 Telephone: 949-608-2900 Fax: 949-608-4417 |
WARNING LETTER
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
April 20, 2017
WL # 26-17
Xiuli (Erin) Zhang, CEO
Naturecom Inc.
8 Rancho Circle
Lake Forest, CA 92630
Dear Ms. Zhang:
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.
Adulterated Dietary Supplements
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.
During the inspection, investigators observed the following significant violations:
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)).
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)
Misbranded Dietary Supplements
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).
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. 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 all requirements of federal law, including FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. 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 actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
Please submit your response to:
Kelly D. Sheppard, Director, Compliance Branch
Food and Drug Administration
Los Angeles District
19701 Fairchild
Irvine, CA 92612
If you have any questions please contact Dr. Raymond W. Brullo, Compliance Officer, at (949) 608-2918.
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Los Angeles District Director
Cc:
David Mazerra, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, California 95899-7435