w & c apothecary – FDA Warning Letter, Jun 17, 2016

An FDA inspection of W & C Apothecary, dba The Apothecary, from June 6-17, 2016, revealed serious deficiencies in sterile drug product production and failure to meet Section 503A conditions of the FDCA. The firm did not receive valid prescriptions for individually-identified patients for a portion of compounded drugs, making them ineligible for exemptions from CGMP, adequate labeling, and FDA approval.

Violations included insanitary conditions: operating an ISO 7 anteroom with a failed HEPA filter, using non-sterile wipes and disinfectant, not using a sporicidal agent in the Laminar Flow Hood (LFH), and inadequate sporicidal contact time. The firm also failed to demonstrate LFH protection for the ISO 5 area.

CGMP violations included inadequate systems for equipment maintenance, cleaning/disinfection, environmental monitoring, and failure to establish/follow procedures for preventing microbiological contamination and validating aseptic processes. The firm also failed to reject non-conforming drug products. These issues caused drug products to be adulterated and misbranded.

The FDA acknowledged the firm's June 17, 2016, commitment to cease sterile compounding and voluntarily recall all sterile products within expiry. If the firm resumes sterile operations, it must correct all insanitary conditions and comply with CGMP regulations, new drug approval requirements, and labeling requirements. A comprehensive assessment, possibly with a third-party consultant, is strongly recommended.