FDA's warning letter to Hauppauge, N.Y.-based NX Generation Ltd. included the following violations: no master manufacturing records for packaging and labeling, no established specifications that ensured that products manufactured by others for repackaging are identified and consistent with any specifications, and incomplete batch production records. The citation for failure of Certificate of Analysis values on incoming products to match label values should be reviewed and examined by those companies that use overages in the manufacture of their products.
Food and Drug Administration
January 25, 2013
Warning Letter: NX Generation Ltd.
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.