BDR Pharmaceuticals International Private Ltd. – FDA Inspection, Nov 20, 2025

Record Details

This FDA Inspection record concerns BDR Pharmaceuticals International Private Ltd., with an inspection on November 20, 2025, issued by the Office of Inspections and Investigations, covering human drugs.

Company: BDR Pharmaceuticals International Private Ltd.
Inspection Date: November 20, 2025
Product Type: Human Drugs
Office: Office of Inspections and Investigations
Person: Wayne D. Mcgrath

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ID · 7eef0b21-d903-4122-92bf-400e76b79102

Inspection Facts

Inspection number: 1292028
FDA center: Human Drugs
Project area: Generic Drug Evaluation
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 211.113(b)Procedures for sterile drug products
21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance

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FDA Inspection

BDR Pharmaceuticals International Private Ltd.November 20, 2025