- TerraVare, Inc.
- Issuing Office:
- New York District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty AvenueJamaica, NY 11433
July 12, 2016
WARNING LETTER NYK-2016-36
VIA UNITED PARCEL SERVICE
Mr. James Hamell, CEO
151 B Highway 9, #182
Black Mountain, NC 28711
Mr. Daniel P. Whitehouse, Production Manager
4022 Mill Rd
Skaneateles, NY 13152-9319
Dear Messer’s Hamell and Whitehouse:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, located in Skaneateles, New York, from March 2, 2016, through March 8, 2016. Our investigation identified serious violations of FDA’s Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your High Frequency Super Food Formula dietary supplement products to be adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(g)(1)] because they have been prepared, packed or held under conditions that do not meet the CGMP regulation for dietary supplements. You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov
Dietary Supplement CGMP Violations
During our inspection of your facility, our investigator observed the following significant violations:
1. You failed to identify who is responsible for your quality control operations, as required by 21 CFR 111.12(b). Specifically, you did not have any quality control personnel employed during our inspection.
We acknowledge your response, dated March 23, 2016, to the Form FDA-483, Inspection Observations issued at the close of the inspection, but we are unable to evaluate the adequacy of your corrective action. In your response, you stated that until such time as you have hired someone to manage the quality management process, you have appointed your plant manager and VP of Operations to manage the quality control process closely. However, each person who is identified to perform quality control operations must be qualified to do so and have distinct and separate responsibilities related to performing such operations from those responsibilities that the person otherwise has when not performing such operations (see 21 CFR 111.12(b)). You have provided no information regarding the qualifications of either your plant manager or VP of Operations to perform such a function, and we note during the inspection your plant manager acknowledged that quality control operations were beyond him.
2. You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use, as required by 21 CFR 111.75(a)(1)(i). Specifically, you have not conducted any tests to verify the identity of the following dietary ingredients used in the manufacturing of your High Frequency Super Food Formula: phytoplankton used in (b)(4); and organic milled chia seed used in (b)(4).
We acknowledge your response, dated March 23, 2016, to the Form FDA-483, Inspection Observations issued at the close of the inspection, but we are unable to evaluate the adequacy of your corrective action. You indicated that you did not perform identity testing on phytoplankton, but did test the milled chia seed and moringa. You further indicated you will do appropriate testing in the future. However, you did not provide testing methodology and identity results to support your assertion that you had conducted the required identity testing for the milled chia seed and moringa, and you did not provide documentation regarding the specific testing you plan to use for each component that is a dietary ingredient.
3. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of 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 manufactured (b)(4) of your High Frequency Super Food Formula dietary supplement without having a written, established MMR.
We acknowledge your response, dated March 23, 2016, to the Form FDA-483, Inspection Observations issued at the close of the inspection, but we are unable to evaluate the adequacy of your corrective action. You stated that you have already updated your records and your internal operating procedures to ensure up-to-date and accurate MMRs, but you failed to provide supporting documentation.
4. 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, the BPRs for your High Frequency Super Food Formula (b)(4) products failed to include the following:
- The date and time of the maintenance, cleaning, and sanitizing of 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, as required by 21 CFR 111.260(c);
- The unique identifier that you assigned to each component, as required by, 21 CFR 111.260(d);
- Documentation that the finished dietary supplement meets specifications established in accordance with § 111.70(e) and (g), as required by 21 CFR 111.260(i);
- Documentation, at the time of performance, of packaging and labeling operations including the unique identifier that you assigned to packaging and labels used, as required by 21 CFR 111.260(k)(1); and
- Documentation at the time of performance that quality control personnel approved and released, or rejected, a batch for distribution, as required by 21 CFR 111.260(l)(3).
We acknowledge your response, dated March 23, 2016, to the Form FDA-483, Inspection Observations issued at the close of the inspection, but we are unable to evaluate the adequacy of your corrective action. You stated that you have already updated your records and your internal operating procedures to ensure up-to-date and accurate BPRs. However, you did not provide copies of the BPRs for your High Frequency Super Food Formula dietary supplement showing the required information relating to the production and control of these batches.
5. Your firm’s quality control operations failed to review and approve all batch production-related records, as required by 21 CFR 111.123(a)(2). Specifically, your “Out-Of-Specification/Variance Form” for the High Frequency Super Food Formula product, (b)(4), as attached to your batch production record, was not reviewed, approved, signed and dated.
Misbranded Dietary Supplement
Your "High Frequency Super Food Formula" product is misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. For example, the label lists the nutrients Omega-3 Fatty Acids and Omega-6 Fatty Acids, which are dietary ingredients that do not have Reference Daily Intake (RDI). However, it is declared in the incorrect order on the Supplement Facts label. In accordance with 21 CFR 101.36(b)(3)(i), dietary ingredients for which FDA has not established RDI's or DRV's must be presented in a column that is under the column for (b)(2)- dietary ingredients. The label incorrectly lists these ingredients between Saturated Fat and Sodium, and are not listed separately from the (b)(2)-dietary ingredients under a heavy bar as described in 21 CFR 101.36(e)(6).
This letter is not an all-inclusive list of violations at your facility or in connection with your products. It is your responsibility to ensure that your products comply with the Act and FDA’s implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice, including, without limitation, seizure or injunction.
You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps toward long-term corrective actions. If you cannot complete all corrective actions before you respond, you should explain the reason for your delay and state when you will correct the remaining deficiencies.
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.
Your written response should be sent the Food and Drug Administration; Attention:
CDR Frank Verni, R.Ph.
U. S. Food and Drug Administration
158-15 Liberty Avenue, Room 4050
Jamaica, NY 11433
If you have any questions about the content of this letter please contact: CDR Verni at (718) 662-5702.
Ronald M. Pace
New York District