NX Generation Ltd. 1/25/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433
January 25, 2013
WARNING LETTER NYK-2013-8
VIA UNITED PARCEL SERVICE
Mr. Michael S. Lewis, President
NX Generation Ltd.
115 Engineers Road
Hauppauge, NY 11788
Dear Mr. Lewis:
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement packaging, labeling and distribution facility, located at 115 Engineers Road, Hauppauge, New York on July 18, 23 & 25, 2012. Our investigation found that you have 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 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
On October 3, 2012 we received your response, dated July 31, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations. We address this response below.
Your significant violations include, but are not limited to, the following:
1. You failed to package and label in a way that ensures that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.415. Specifically, you verbally confirmed to our investigator that your firm does not have written master manufacturing records for the packaging and labeling of approximately (b)(4) dietary supplements, including children’s chewable and prenatal dietary supplement products that you package and label at your facility. 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)].
We reviewed your July 31, 2012 dated response and determined that it is inadequate. Your response included Standard Operating Procedures (SOPs) related to packaging, lot number assignment, components, and labeling. However, your response did not include any master manufacturing records related to your packaging and labeling operations.
2. Your firm failed to establish specifications to provide sufficient assurance that products your firm receives from a supplier for packaging or labeling and distribution as dietary supplements are adequately identified and are consistent with your purchase order, as required by 21 CFR 111.70(f). Specifically, your firm did not establish specifications for the products (approximately (b)(4) dietary supplements) your firm receives in bulk for repackaging and labeling as dietary supplements, including but not limited to children's chewable and prenatal supplements. Currently, your firm compares the Certificate of Analysis (COA) that accompanies incoming dietary supplements to the COA received with a previous lot of bulk dietary supplements and your firm has not established its own specifications.
We reviewed your July 31, 2012 dated response and determined that it is inadequate. You provided a template Product Specification Sheet for Dietary Supplement, but did not list any product specifications under 21 CFR 111.70(f) to comply with this requirement for the products you package and label.
3. Your batch production records (BPR) 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 BPR for your packaged and labeled dietary supplements does not include the following required information:
a. The identity of equipment and processing lines used in producing the batch [21 CFR 111.260(b)];
b. 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, as required by 21 CFR 111.260(c).
c. The results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)];
d. Documentation, at the time of performance, of packaging and labeling operations, as required by 21 CFR 111.260(k). Specifically, you failed to include:
i. The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and reconciliation of any discrepancies between issuance and use of labels, as required by 21 CFR 111.260(k)(1); and
e. Documentation, at the time of performance, that quality control personnel reviewed the BPR, and approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement [21 CFR 111.260(l)(1) and (4)].
We have reviewed your response dated July 31, 2012 and have determined that it is inadequate. Your equipment cleaning and use record submitted to us as part of your July 31, 2012 response to the FDA-483 failed to identify your equipment (e.g., (b)(4) brand bottle fillers, tablet dispenser) used in the packaging and labeling of dietary supplement and failed to list the date or time of the maintenance and sanitizing of the equipment. Further, this record does not list the processing line (e.g., packaging lines) to package and label your dietary supplements. You also indicated to our investigator that your employee weighs out 100 tablets on your (b)(4) brand scale, but your batch record does not include a field where this examination can be recorded. Further, your Master Packaging Record and Batch Production Record (BPR) do not provide a field where a unique identifier that you assigned to packaging and labeling or that quality control personnel reviewed the BPR, and approved and release, or rejected, the packaged and labeled dietary supplement.
4. You failed to have quality control operations for packaging and labels before use in the manufacture of a dietary supplement, as required by 111.120. Specifically, you failed to have quality control operations determining whether all packaging and labels conform to packaging and label specifications [21 CFR 111.120(b)]. During the inspection, our investigator reviewed your firm’s labels for the Unique brand of Children’s Chewable Vitamins (100 Tablets) and Unique brand of Prenatal Care (100 Film-Coated Tablets) against the accompanying Certificate of Analysis (COA) from (b)(4) and (b)(4), respectively. Your records indicate that (b)(4) (100 count) bottles of Children’s Chewable Vitamins and (b)(4) (100 count) bottles of Prenatal Care were packaged and labeled on July 18, 2012. The following discrepancies were noted between the product labels and the COAs:
Name of Product
Product label value
Children’s Chewable Vitamin
Your quality control operations failed to determine if these labels meet labeling specifications under 21 CFR 111.70(d) and why they did not match up to the COA.
5. Your firm failed to make and keep written procedures for returned dietary supplements, as required by 21 CFR 111.535(b)(1). Specifically, you did not have written procedures for handling any returned dietary supplements, including when a returned dietary supplement may be salvaged, in accordance with 21 CFR 111.520, or when a returned dietary supplement must be destroyed or otherwise suitably disposed of in accordance with 21 CFR 111.515.
We reviewed your responses to observations # 3, 5, 6, 7, 8, and 9 and the responses appear to be adequate. We will verify the adequacy of them during our next inspection.
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable FDA regulations, including the CGMP regulation for dietary supplements. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
We also provide the following labeling comment. Under 21 CFR 101.36(b)(2)(iii), the percent of the daily value must be declared for all dietary ingredients for which FDA has established daily values. Specifically, the labels of your Unique Children’s Chewable Vitamins and Unique Prenatal Care dietary supplement products lists incorrect percent daily values (% DV) based on the established RDI. The RDI's for each of the dietary ingredients can be found in 21 CFR 101.9(c)(8)(iv). Specifically, your label for the Children’s Chewable Vitamins lists the RDI for Vitamin E as 15 IU and Niacin as 13.5 mcg, but you incorrectly list the %DV for both children of the age 2 to 4 and 4 and over incorrectly (i.e., Vitamin E, 150% and 100%, respectively) and (i.e., Niacin, 150% and 68%, respectively). Further, your label for the Prenatal Care lists the RDI for Vitamin A as 4000 IU, Riboflavin as 1.7, Niacin as 16 mg, Vitamin B6 as 2.6 mg, Folic Acid as 0.8 mg, Vitamin B-12 as 4 mcg, and Calcium as 200 mg, but you incorrectly list the %DV for these dietary ingredients.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. 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 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 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.
Your written response should be sent the Food and Drug Administration; Attention:
LCDR Frank Verni
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: LCDR Verni at (718) 662-5702.
Ronald M. Pace
New York District