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News about "Pre-Approval Inspection "
Dr. Reddy's Biologics Facility in Hyderabad Receives USFDA Form 483 with Five Observations
The USFDA has completed a Pre-Approval Inspection (PAI) at Dr. Reddy's biologics manufacturing facility in Bachupally, Hyderabad, with five observations.
Pre-Approval Inspection | 13/09/2025 | By Dineshwori | 123
Lupin's Aurangabad Facility Gets Two Observations After US FDA Inspection
The United States Food and Drug Administration (US FDA) has completed a product-specific pre-approval inspection at Lupin’s Chhatrapati Sambhajinagar (Aurangabad) manufacturing facility, issuing two observations.
Pre-approval Inspection | 06/09/2025 | By Dineshwori
Granules India Unit V Facility Completes US FDA Inspection with Zero 483 Observations
Granules India Ltd. has announced that the company’s Unit V facility has completed the US Food and Drug Administration (FDA) inspection between April 8-12, 2024, resulting in zero 483 observations.
Pre-Approval Inspection | 15/04/2024 | By Aishwarya | 778
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