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I spoke to a former VP of quality at the PDA/FDA Joint Regulatory Conference. He said one of his bad 483s probably cost him $5 million. And that’s cheap – that’s just a 483. What about a warning letter? There is an even greater magnitude of reputation damage, impact on new drug approvals, etc. This post describes the full scope and includes articles/case studies.
by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Acquisition of one pharmaceutical firm by another is preceded by due diligence efforts in
by Barbara Unger, FDAzilla GMP Quality Expert INDIA | IMPORT ALERT 66-40 and Association with Warning Letters Regarding These Sites | Detention Without Physical Examination of Drugs