FDA WARNING_LETTER - Rasi Laboratories, Inc. - September 03, 2010

From August 17 to September 3, 2010, the FDA inspected Rasi Laboratories, Inc. in Somerset, New Jersey, identifying serious violations of Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR Part 111), rendering products adulterated.

Key violations include: 1. **Failure to meet product specifications prior to distribution (21 CFR 111.73, 111.75(c)):** Finished dietary supplement batches (e.g., Melatonin 10mg, Vibrance Multivitamin, Complete Joint Care) were distributed before identity, purity, strength, and composition testing was completed. The firm's response, citing a customer agreement to hold product, was deemed inadequate as it violated 21 CFR 111.123(a)(8), 111.123(b), 111.77, and their own SOP WH002. 2. **Failure to follow written sampling plans (21 CFR 111.315(b)(1)):** The Quality Control Unit did not adhere to SOP QC018 for raw material sampling, routinely collecting only one sample instead of the required square root of (n) + one. The firm's response indicating corrective action was noted as appearing adequate, pending verification. 3. **Failure to hold components and