A June inspection now has the FDA hitting Dr. | The agency spotted seven observations at Dr. Reddy's Bachupally, Hyderabad, biologics plant following a mid-June inspection.
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The U.S. FDA issues seven observations to Dr. Reddy's Hyderabad biologics facility following a pre-licence inspection.
Dr. Reddy’s Srikakulam facility receives three observations from U.S. FDA after recent Pre-Approval and GMP inspections.
In an initiative to increase the efficiency of drug manufacturing in the United States, the FDA has
From Indiana to Iceland, the FDA this week disclosed concerns raised during recent visits to a pair of manufacturing sites with…
After a site visit by FDA inspectors yielded a Form 483 for Genzyme Ireland in early 2026, the Sanofi subsidiary is facing…
Following an inspection earlier this year that yielded a Form 483, Indian generics juggernaut Alembic Pharmaceuticals has…
