Alder Biochem Private Limited – FDA Inspection, Aug 14, 2026

Record Details

This FDA Inspection record concerns Alder Biochem Private Limited, with an inspection on August 14, 2026, issued by the Office of Inspections and Investigations, covering human drugs.

Company: Alder Biochem Private Limited
Inspection Date: August 14, 2026
Product Type: Human Drugs
Office: Office of Inspections and Investigations
Person: Karishma G. Gopaul (FDA Associated Person)

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ID · 1c1d6609-c3c3-46cf-9a63-c0dd98043593

Inspection Facts

Inspection number: 1331592
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.194(a)(2)Suitability of testing methods verified

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FDA Inspection

Alder Biochem Private LimitedAugust 14, 2026