# MSN Laboratories Private Limited – FDA 483, Aug 14, 2026

Source: https://www.keypedia.com/records/483/msn-laboratories-private-limited/4469a7e3-faed-4bc0-8f8a-492347a54de0

> FDA 483 for MSN Laboratories Private Limited on August 14, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MSN Laboratories Private Limited
- Inspection Date: 2026-08-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of MSN Laboratories Private Limited, an API manufacturer in Patancheru, India, revealed a significant quality control issue. The firm failed to conduct adequate testing for several critical raw materials used in the production of active pharmaceutical ingredients for the U.S. market. This deficiency impacts numerous batches of various APIs produced since January 2026.

## Related Documents

- [EIR - 2019-12-20](https://www.keypedia.com/records/eir/msn-laboratories-private-limited/ae303a0a-36fa-40bb-89e5-2917e9d5df63) — date: December 20, 2019
- [483 - 2016-06-23](https://www.keypedia.com/records/483/msn-laboratories-private-limited/b1bf84da-4acd-4e7e-af4a-f75dea2a3e1d) — date: June 23, 2016

## Related Officers

- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

Company: https://www.keypedia.com/companies/msn-laboratories-private-limited/c72800c4-c988-4f52-be08-6bcf51eed33d

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