FDA WARNING_LETTER - Crosbys Drugs Inc - September 16, 2016

An FDA inspection of Crosby's Drugs Inc. from September 12-16, 2016, revealed significant violations. The firm failed to meet Section 503A of the FDCA conditions for exemption from certain provisions, specifically by not receiving valid prescriptions for individually-identified patients for a portion of compounded drug products. This renders these "ineligible drug products" subject to FDA approval, adequate labeling, and CGMP requirements.

The inspection also found serious deficiencies in sterile drug product production, leading to adulterated products under FDCA Section 501(a)(2)(A) due to insanitary conditions. Examples include an operator donning a non-sterile coverall that touched the floor, failure to depyrogenate glassware, lack of media fill studies, and inadequate demonstration of hood protection for the ISO 5 area.

Furthermore, the "ineligible drug products" were adulterated under Section 501(a)(2)(B) due to significant CGMP violations. These included failure to establish written procedures for preventing microbiological contamination (21 CFR 211.113(b)), inadequate stability testing (21 CFR 211.166(a)), improper personnel clothing (21 CFR 211.28(a)), insufficient container closure processing (21 CFR 211.94(c)), inadequate environmental monitoring (21 CFR 211.42