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

Source: https://www.keypedia.com/records/483/msn-laboratories-private-limited/2e9188f0-84d3-4552-a148-f311a8756e64

> FDA 483 for MSN Laboratories Private Limited on December 11, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MSN Laboratories Private Limited
- Inspection Date: 2025-12-11
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Documents

- [483 - 2025-12-11](https://www.keypedia.com/records/483/msn-laboratories-private-limited/dc83464d-37fe-4cff-b3ae-dbd342733b8d)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Drug Investigator](https://www.keypedia.com/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

Company: https://www.keypedia.com/companies/msn-laboratories-private-limited/8607ae94-bf26-4a3a-be3a-b93495bac216

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8