Custom Research Labs Inc – FDA Warning Letter, Jun 4, 2021

The FDA issued a Warning Letter to Custom Research Labs Inc. following a June 1-4, 2021, inspection, citing significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated. Additionally, "(b)(4)," "(b)(4) HAND SANITIZER," and "BAK-OFF Instant Hand Sanitizer" were identified as unapproved new drugs and misbranded.

Key violations include: 1. **Inadequate Component Testing (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm failed to test incoming APIs (camphor, menthol) and DI water for identity, purity, strength, and quality, relying on unvalidated supplier COAs. Water system design and monitoring were also deficient, with elevated bioburden and out-of-specification pH, a repeat observation from a 2016 inspection. Corrective actions require detailed testing procedures, supplier qualification, and a comprehensive water system assessment. 2. **Failure to Validate Production Processes (21 CFR 211.100(a)):** The manufacturing process for "(b)(4)" drug product was unvalidated, despite multiple batches being in distribution, a repeat observation from 2016. The firm must provide a detailed validation program and timeline for all marketed drug products. 3. **Inadequate