FDA WARNING_LETTER - Nutro Laboratories, a div of NBTY, Inc. - October 29, 2010

On October 13-29, 2010, the FDA inspected Nutro Laboratories' dietary supplement facility in South Plainfield, New Jersey, identifying serious violations of Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR Part 111). These violations render products adulterated under section 402(g)(1) of the Act.

Key violations include: 1. **Failure to establish component specifications:** Nutro Laboratories did not establish a purity specification for Crospovidone, specifically for peroxide levels, despite being notified by a supplier of high peroxide in lot# PKVX09126031. The company's response, claiming an updated specification of <400 ppm, was inadequate due to a lack of supporting documentation. Additionally, actions for products manufactured with Crospovidone lot# PKVX091027006, which FDA testing showed had peroxide levels exceeding 400 ppm, were not indicated. 2. **Failure to qualify suppliers:** Nutro Laboratories did not establish the reliability of the Certificate of Analysis (COA) for Crospovidone lot PKVX090802168 by confirming supplier test results for parameters like pH, Water-soluble substances, Residue on Ignition, and Assay. The company's response was deemed inadequate as it did not clarify updated specifications or their inclusion in the supplier qualification program.