Alphamed Formulations Private Limited – FDA Inspection, Dec 5, 2025

Record Details

This FDA Inspection record concerns Alphamed Formulations Private Limited, with an inspection on December 5, 2025, issued by the Office of Inspections and Investigations, covering human drugs.

Company: Alphamed Formulations Private Limited
Inspection Date: December 5, 2025
Product Type: Human Drugs
Office: Office of Inspections and Investigations
Person: Zachary L. Stamm (FDA Associated Person)

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ID · 4b07cfe4-1d5e-4ef5-b92f-88f714e2824e

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1294160
FDA center: Human Drugs
Project area: New Drug Evaluation
Outcome: Form 483 issued

FDA Citations

21 CFR 211.194(a)Complete test data included in records

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FDA Inspection

Alphamed Formulations Private LimitedDecember 5, 2025