FDA WARNING_LETTER - Pharmalab Enterprises, Inc. - June 17, 2019

The FDA inspected Pharmalab Enterprises, Inc. from May 29 to June 17, 2019, identifying significant CGMP violations for finished pharmaceuticals, dietary supplements, and misbranded food products. Drug products are adulterated under 21 U.S.C. 351(a)(2)(B) due to non-conforming manufacturing methods, facilities, or controls. The Rabano Yodada with Noni and Vitamins product is also an adulterated dietary supplement under 21 U.S.C. 342(g)(1) due to serious violations of 21 CFR Part 111.

Key violations include: 1. **Inadequate Laboratory Controls (21 CFR 211.160(b)):** Microbial specification limits for OTC drug products like Rompe Pecho were scientifically unjustified and exceeded appropriate limits for oral use. High microbial counts (220-2,800 cfu/mL) were observed in Rompe Pecho lots. 2. **Insufficient Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate high microbial counts in drug products, relying on retesting rather than identifying root causes. Antimicrobial effectiveness studies for multi-use drug products were insufficient, and previously distributed batches with inadequately preserved formulations were not addressed. 3. **Inadequate Production and Process Controls (21 CFR