FDA WARNING_LETTER - Stewart Compounding Pharmacy - March 25, 2013

From March 18 to March 25, 2013, an FDA inspection of Stewart Pharmaceuticals, Inc. (dba Stewart Compounding Pharmacy) identified serious violations. The firm was producing a significant number of drug products without valid prescriptions for individually-identified patients, which means these drugs do not qualify for exemptions under section 503A of the FDCA or FDA's enforcement discretion per CPG 460.200. This renders them misbranded under section 502(f)(1) of the FDCA because they lack adequate directions for use.

Furthermore, the inspection revealed serious deficiencies in sterile drug product production, leading to adulteration under section 501(a)(2)(A) and 501(a)(2)(B) of the FDCA. Violations included performing processing and filling of syringes in an unclassified area without further sterilization, lack of smoke studies, unsuitable and improperly tested sterilization equipment, and personnel not using sterile garments. Since the firm manufactures and distributes drugs without valid prescriptions, its operations are subject to CGMP regulations (21 CFR Parts 210 and 211). Specific CGMP violations included failure to establish and follow procedures for preventing microbiological contamination (21 CFR 211.113(b)), inadequate personnel clothing (21 CFR 211.28(a)), insufficient environmental monitoring (21 CFR 211.