FDA WARNING_LETTER - San Diego Compounding Pharmacy - November 15, 2016

The FDA issued a Warning Letter to San Diego Compounding Pharmacy, P.C. following an inspection from October 17 to November 15, 2016. The inspection revealed that drug products produced by the firm failed to meet the conditions of section 503A of the FDCA, specifically by not receiving valid prescriptions for individually-identified patients. This renders these products ineligible for exemptions from CGMP, adequate directions for use, and FDA approval requirements.

Furthermore, the FDA investigator noted serious deficiencies in sterile drug production. Drug products intended to be sterile were prepared under insanitary conditions, making them adulterated under section 501(a)(2)(A) of the FDCA, exemplified by a failure to measure pressure differentials. Significant CGMP violations were also observed, causing ineligible drug products to be adulterated under section 501(a)(2)(B) of the FDCA. These included failure to establish and follow written procedures to prevent microbiological contamination and validate aseptic processes (21 CFR 211.113(b)), and failure to establish an adequate environmental monitoring system (21 CFR 211.42(c)(10)(iv)). Additionally, ineligible drug products were misbranded under section 502(f)(1) of the FDCA due to inadequate directions for use.

The firm responded by stating it would not renew its Licensed Sterile Compounding (LSC) License. The FDA recommends a comprehensive assessment, potentially with a third-party consultant, if the firm decides to resume sterile drug production. The firm must notify the FDA within 15 working days of corrective actions or intent not to resume sterile production, and 15 days prior to any future resumption of sterile drug production. Failure to correct violations may result in legal action.