Pharmedium Services, LLC – FDA Warning Letter, Mar 22, 2013

This FDA Warning Letter, CHI-10-14, issued to PharMEDium Services, LLC, details serious deficiencies in sterile drug product manufacturing observed during inspections from February 19 to March 22, 2013, at facilities in Cleveland, MS; Edison, NJ; Memphis, TN; and Sugar Land, TX. The inspections resulted in Form FDA 483s.

Key violations include insanitary conditions and significant Current Good Manufacturing Practice (CGMP) violations. Insanitary conditions observed were operators not properly sanitizing hands, processing sterile products with exposed skin and non-sterile masks, re-using gowns, inadequate personnel monitoring, and insufficient airflow studies for ISO 5 areas. CGMP violations cited include inadequate facility design and defined areas to prevent contamination (21 CFR 211.42(b), (c)), failure to establish and follow procedures to prevent microbiological contamination (21 CFR 211.113(b)), inappropriate personnel clothing (21 CFR 211.28(a)), inadequate environmental monitoring (21 CFR 211.42(c)(10)(iv)), inadequate equipment maintenance for aseptic conditions (21 CFR 211.42(c)(10)(vi)), and insufficient stability and final product testing (21 CFR 211.166(a), 211.167(a),