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Tag: Equipment maintenance

News World

FDA issues Form 483s to Japanese, Indian drugmakers in wake of plant inspections

  • Post Author By Health Herald
  • Post Date September 11, 2024
  • Post Comment 0 comments

Two Japanese drugmakers and another in India were hit with Form 483s from the FDA following inspections that uncovered issues ranging from a lack of […]

Tagged API manufacturer, API specifications, Aseptic processing areas, Biocon Biologics, Contamination prevention procedures, Cross-contamination prevention, Employee training in GMP, Environmental monitoring, Equipment cleaning procedures, Equipment maintenance, FDA Form 483, Good manufacturing practices (GMP), Indian drugmaker, Japanese drugmakers, Laboratory test procedures, Mobara facility inspection, Otsuka Pharmaceutical, Production data controls, Sanitary procedures, Taenaka Kogyo, Tokushima facility inspection, Unexplained discrepancies investigation, Ventilation systems contaminationLeave a Comment on FDA issues Form 483s to Japanese, Indian drugmakers in wake of plant inspections

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