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Form 483
Manufacturing
FDA issues Form 483 to Dr. Reddy's plant in India
The agency spotted seven observations at Dr. Reddy's Bachupally, Hyderabad, biologics plant after a mid-June inspection.
Zoey Becker
Jun 26, 2026 11:40am
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
Takeda, Innovent-Lilly, Roche—Fierce Pharma Asia
Oct 31, 2025 8:20am
FDA scolds Hetero over missteps at India warehouse
Oct 28, 2025 10:00am
Novo plant issues may mean delays for Regeneron, Scholar Rock
Oct 13, 2025 3:48pm
