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FDA inspection
Pharma
Sanofi unit in Ireland dinged by FDA on Altuviiio production
After a site visit by FDA inspectors yielded a Form 483 for Genzyme in early 2026, the Sanofi unit is facing further scrutiny from the regulator.
Fraiser Kansteiner
Jul 1, 2026 2:52pm
FDA issues Form 483 to Dr. Reddy's plant in India
Jun 26, 2026 11:40am
FDA unveils 1-day assessment pilot to complement inspections
May 6, 2026 3:08pm
FDA clarifies Form 483 expectations after production inspections
May 1, 2026 10:52am
FDA hit Catalent's Maryland manufacturing sites with Form 483
Dec 19, 2025 11:36am
Alvotech plant issues trigger another FDA biosimilar rejection
Nov 4, 2025 7:40am
