FDA warns Indian firm over cleanliness and poor record keeping, US drugmaker over investigation failures
Regulatory NewsJoanne S. Eglovitch
Audit/inspectionCBERCDERComplianceGMPHuman cells, tissues, and cellular and tissue-based products (HCT/Ps)OTCPharmaceuticalsQuality Assurance and ControlRecallsRegulatory Intelligence/PolicyUnited StatesWarning letters