FDA WARNING_LETTER - Precise Nutrition International, Inc. - December 21, 2012

On July 11, 2013, the FDA issued a Warning Letter to Precise Nutrition International, Inc. following an inspection from December 10-21, 2012. The inspection revealed serious violations of dietary supplement CGMP regulations (21 CFR Part 111), causing their VitalErotic Shot product to be adulterated.

Key violations include: 1. **Failure to verify identity of dietary ingredients (21 CFR 111.75(a)(1)(i)):** The firm relied solely on supplier COAs for ingredients like L-Arginine HCL and Yohimbine HCL, which is insufficient. The firm's response was inadequate as no documentation of implemented corrective action was provided. 2. **Failure to establish specifications (21 CFR 111.70):** No specifications were established for component identity, purity, strength, composition, or contamination limits. Additionally, there were no in-process specifications for bulk liquid storage time (observed 11-199 days between blending and filling) or documentation to support product quality after such storage. The firm's response lacked documentation of implemented procedures and detailed stability study parameters. 3. **Failure to verify finished product specifications (21 CFR 111.75(c)):** Six of seven VitalErotic Shot lots lacked documentation of finished product testing. The firm's stated "