FDA WARNING_LETTER - I.V. Specialty, Ltd - July 22, 2014

The FDA issued a Warning Letter to I.V. Specialty, Ltd., following an inspection from July 14-22, 2014, when the facility was registered as an outsourcing facility. The inspection revealed serious deficiencies in sterile drug product manufacturing, posing patient risk.

Violations included operators processing sterile drugs with exposed hair, ears, and forehead; placing unsanitized materials and using non-sterile wipes in ISO 5 hoods; failing to use sporicidal cleaning agents for ISO 5 horizontal laminar airflow (LAF) hoods; and failing to demonstrate adequate protection of ISO 5 areas. These conditions led to drug products being adulterated under FDCA sections 501(a)(2)(A) (insanitary conditions) and 501(a)(2)(B) (CGMP violations).

Specific CGMP violations cited were failure to establish written procedures for preventing microbiological contamination (21 CFR 211.113(b)), inadequate cleaning and disinfection systems (21 CFR 211.42(c)(10)(v)), lack of equipment maintenance for aseptic conditions (21 CFR 211.42(c)(10)(vi)), improper personnel gowning (21 CFR 211.28(a)), inadequate environmental monitoring (21 CFR 211.42(c)(10)(iv)), and lack of final product conformance testing