Food & Drug Inspection Monitor

摘要

Inspections Featured This Month: Human Drugs — Boehringer Ingelheim Vetmedica, Elwood, KS; Diversified Manufacturing Corp., Newport MN. Medical Devices — Ram Precision Industries, Centerville, OH. Biologies — Chesapeake Biological Laboratories, Baltimore, MD. EIR Denials — Inspection Log. Final guidance for GMP inspection dispute resolution does not cover PAIs: FDA Jan. 11 released its final guidance titled "Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP," which does not apply to pre-approval or pre-licensing inspections, and the agency noted that existing Center guidance would apply to those audits.