Food & Drug Inspection Monitor

摘要

Pitfalls seen for API audits under European Union's new inspection plan; Pre-approval inspection for Allergan finds lack of validation and numerous media fill flaws; DSM nets one-item 483 for data flaws in process monitoring for APIs; Device firm hitwith 9-item 483 citing validation and lack of corrective actions; 9-item 483 to Hamilton Medical for MDRs, CAOAs and quality audits; Audiology equipment manufacturer fails to implement quality system; Wood Hygienic inspected for selling colonic units without PMA, netting 8-item 483.