NX Generation Ltd. – FDA Warning Letter, Jul 25, 2012

The FDA inspected NX Generation Ltd.'s dietary supplement packaging, labeling, and distribution facility in Hauppauge, NY, on July 18, 23, and 25, 2012. The inspection revealed serious violations of FDA's Current Good Manufacturing Practice (CGMP) regulation for dietary supplements (21 CFR Part 111), rendering their products adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to use Master Manufacturing Records (MMRs):** The firm lacked written MMRs for packaging and labeling approximately (b)(4) dietary supplements, including children's chewable and prenatal products, as required by 21 CFR 111.415. The provided SOPs were deemed inadequate as they did not include MMRs. 2. **Failure to establish product specifications:** The firm did not establish specifications for bulk dietary supplements received for repackaging and labeling (e.g., children's chewable and prenatal supplements), relying instead on comparing supplier Certificates of Analysis (COAs) to previous lots, violating 21 CFR 111.70(f). A template provided was insufficient. 3. **Incomplete Batch Production Records (BPRs):** BPRs lacked required information, including equipment identity (21 CFR 111.260