FDA WARNING_LETTER - California Pharmacy & Compounding Center - October 17, 2014

On June 17, 2015, the FDA issued a Warning Letter to California Pharmacy & Compounding Center (CPCC) following inspections from August 18-25, 2014, and October 14-17, 2014. CPCC, registered as an outsourcing facility under FDCA section 503B, was cited for serious deficiencies in sterile drug production, rendering products adulterated and misbranded.

Key violations include: - **Insanitary Conditions (501(a)(2)(A) FDCA):** Failure to monitor pressure differential between cleanroom and anteroom, and absence of environmental monitoring during sterile production periods (Jan-June 2014), posing contamination risk. - **CGMP Violations (501(a)(2)(B) FDCA):** Lack of written procedures for preventing microbiological contamination and validating aseptic processes (21 CFR 211.113(b)); inadequate personnel gowning (21 CFR 211.28(a)); insufficient environmental monitoring system (21 CFR 211.42(c)(10)(iv)); failure to investigate discrepancies (21 CFR 211.192); and inadequate equipment maintenance for aseptic conditions (21 CFR 211.42(c)(10)(vi)). - **Failure to Meet 5