FDA WARNING_LETTER - Alexander Infusion LLC D/B/A Avanti Health Care - July 09, 2014

This FDA Warning Letter (NYK-2015-27) was issued to Alexander Infusion, LLC (dba Avanti Health Care Services) following an inspection from June 23 to July 9, 2014. The facility, registered as an outsourcing facility under FDCA section 503B, was found to have serious deficiencies in producing sterile drug products, posing patient risk.

Violations include: - **Insanitary Conditions (FDCA 501(a)(2)(A)):** Operators processed sterile drugs in ISO 5 areas with exposed facial skin/hair and used sterile gloves over non-sterile, non-disinfected gloves without proper aseptic technique. The firm failed to demonstrate adequate protection of ISO 5 areas by hoods. - **CGMP Violations (FDCA 501(a)(2)(B)):** Failure to establish written procedures for preventing microbiological contamination and validating aseptic processes (21 CFR 211.113(b)); inadequate personnel clothing (21 CFR 211.28(a)); no system for maintaining aseptic equipment (21 CFR 211.42(c)(10)(vi)); inadequate cleaning/disinfecting system (21 CFR 211.42(c)(10)(v)); inadequate environmental monitoring (21 CFR 211.42(c)(10)(iv