FDA WARNING_LETTER - Hemofarm A.d. - November 22, 2011

This FDA Warning Letter to Hemofarm A.D. dated June 20, 2012, details significant Current Good Manufacturing Practice (CGMP) violations observed during a November 14-22, 2011, inspection of their pharmaceutical manufacturing facility in Vrsac, Serbia. These violations render their drug products adulterated under 21 U.S.C. § 351(a)(2)(B).

Key violations include: 1. **Unreliable Environmental Monitoring (21 C.F.R. § 211.160(b)):** The firm used dried agar plates, failed to report microbial growth, had inconsistent environmental data, inadequate sampling procedures (lacking diagrams, insufficient air samples), and improper agar levels on contact plates. Bioburden testing of components was also inadequate, with analysts manually determining agar temperature. 2. **Inadequate Aseptic Processing (21 C.F.R. § 211.113(b)):** Observed during water runs, operators compromised sterility by leaning over open vials, exposing connections to Grade B areas, and continuing work with wet gowns. Uncovered components were transported through Grade B areas. 3. **Insufficient Investigations (21 C.F.R. § 211.192):** The firm failed to adequately investigate three media fill failures on an aseptic filling line, including