Absolute Pharmacy, LLC – FDA Warning Letter, Nov 19, 2014

On April 27, 2015, the FDA issued Warning Letter FLA-15-21 to Absolute Pharmacy, LLC, an outsourcing facility registered under section 503B of the FDCA. An inspection from October 27 to November 19, 2014, revealed serious deficiencies in sterile drug product manufacturing, posing patient risks.

Key violations include: - **Insanitary Conditions:** Sterile products were prepared under conditions that could lead to contamination, making them adulterated under FDCA section 501(a)(2)(A). Examples include only one viable particle monitoring event since registration and failure to demonstrate adequate protection of the ISO 5 area. - **CGMP Violations:** Significant Current Good Manufacturing Practice (CGMP) violations, causing drug products to be adulterated under FDCA section 501(a)(2)(B). Specific failures include inadequate environmental monitoring (21 CFR 211.42(c)(10)(iv)), lack of validated aseptic procedures (21 CFR 211.113(b)), improper container closure processing (21 CFR 211.94(c)), inadequate air supply (21 CFR 211.42(c)(10)(iii)), no time limits for production phases (21 CFR 211.111), and insufficient laboratory testing for final product specifications (2