MSN Laboratories Private LimitedDecember 11, 2025

FDA 483 - MSN Laboratories Private Limited - December 11, 2025

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Record Details

MSN Laboratories Private Limited, a sterile drug manufacturer in Farooqnagar Mandal, India, was cited for significant deficiencies during an FDA inspection. Observations included failures in equipment performance qualification, inadequate raw material testing, and a quality unit that did not follow procedures for approving specifications and releasing batches. Additionally, the firm lacked scientifically sound environmental monitoring practices and laboratory controls for product quality assurance.

Company: MSN Laboratories Private Limited
Inspection Date: December 11, 2025
Product Type: Drugs
Office: Office of Inspections and Investigations
People: Brandy N. Lepage (Consumer Safety Officer)
Jessica S. Estriplet (Drug Investigator)

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ID · 2e9188f0-84d3-4552-a148-f311a8756e64