buffalo pharmacies inc. – FDA Warning Letter, Jun 23, 2017

The FDA issued a Warning Letter to Buffalo Pharmacies, Inc. DBA Swan Prescription Center following a June 20-23, 2017 inspection. The inspection revealed that drug products produced by the firm failed to meet the conditions for exemption under Section 503A of the FDCA, specifically by not receiving valid prescriptions for individually-identified patients for a portion of their products. This renders these "ineligible drug products" subject to FDA approval, adequate labeling, and CGMP requirements.

The firm's sterile drug products were found to be adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions, including: - Failure to use sporicidal agents or sterile wipes, and using non-sterile disinfectant in the aseptic processing area. - Failure to conduct media fills to simulate aseptic operations. - Operator's bare hands exposed within the ISO 5 work area during sterile glove donning. - No viable or non-viable monitoring under dynamic conditions in the ISO 5 area. - Failure to demonstrate adequate protection of the ISO 5 area by the hood.

Furthermore, the ineligible drug products were adulterated under section 501(a)(2)(B) of the FDCA due to significant CGMP violations, such as: - Inadequate cleaning/disinfection system for aseptic conditions (21 CFR 211.42(c)(10