KRS Global Biotechnology, Inc – FDA Warning Letter, Mar 17, 2014

This FDA Warning Letter (FLA-15-27), dated July 6, 2015, addresses KRS Global Biotechnology, Inc., an outsourcing facility registered under section 503B of the FDCA. An inspection from March 4-17, 2014, revealed serious deficiencies in sterile drug production, putting patients at risk.

Key violations include: - **Insanitary Conditions (501(a)(2)(A) FDCA):** Operators manually stoppering vials with gloved hands, inadequate cleanroom pressure differential monitoring, and environmental monitoring not conducted daily. - **CGMP Violations (501(a)(2)(B) FDCA):** Failure to establish procedures to prevent microbiological contamination (21 CFR 211.113(b)), inadequate facility design to prevent contamination (21 CFR 211.42(b)), inadequate environmental monitoring system (21 CFR 211.42(c)(10)(iv)), and lack of final product specification conformance determination (21 CFR 211.167(a)). - **Failure to Meet 503B Conditions:** Incomplete labeling (missing "This is a compounded drug," compound date, storage/handling, inactive ingredients, adverse event reporting info) and failure to submit initial drug product reports. Consequently, products are not exempt from FDA approval, adequate directions