Tag: Process Validation

USFDA 483 to Novo Nordisk Cite Lapses in

FDA has published the USFDA Form 483 issued to Novo Nordisk API manufacturing facility at

USFDA Issues Warning Letter to Zydus: Fl

Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,

FDA 483 to DRL : Issues in Analytical Va

USFDA 483 issued to Dr.Reddys (DRL) API unit in Pydibhimavaram, India cites failure to validate

Lapses in Process Validations: Torrent U

An USFDA 483 (2019) to Torrent cites deficient Process validation practices and procedures. The observations