FDA WARNING_LETTER - Beauty Manufacturing Solutions Corp. - June 30, 2017

The FDA inspected Beauty Manufacturing Solutions Corp. from June 19-30, 2017, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm's July 24, 2017, response was deemed inadequate.

Violations include: 1. **Failure to investigate discrepancies (21 CFR 211.192):** The firm failed to investigate water system test results showing microorganism levels "too numerous to count" (TNTC) on 25 of 96 days, despite using this water as a major component in OTC drug products and having written procedures requiring investigation for results above (b)(4) cfu/mL. The water system is considered fundamentally flawed. The firm's response, citing bulk product tests meeting specifications, was inadequate as it didn't address the investigation failure or commit to a comprehensive system redesign and ongoing control program to meet USP purified water specifications and appropriate microbial limits. * **Required Actions:** Provide a comprehensive water system evaluation and CAPA, an effective ongoing control program ensuring USP purified water quality, a detailed risk assessment of affected drug product lots (prioritizing TNTC days, extending to all potentially affected lots), and a thorough assessment of overall investigation systems, including enhanced quality unit oversight.

2. **Inadequate laboratory controls (21 CFR 211.160(b)):** Microbiological test