# FDA 483 - MSN Laboratories Private Limited (Formulations Division, Unit-II) - June 20, 2019

Source: https://www.globalkeysolutions.net/records/483/msn-laboratories-private-limited-formulations-division-unit-ii/b54c9c76-a591-428d-9e20-8fadbfdd0c09

> FDA 483 for MSN Laboratories Private Limited (Formulations Division, Unit-II) on June 20, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MSN Laboratories Private Limited (Formulations Division, Unit-II)
- Inspection Date: 2019-06-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of MSN Laboratories Pvt. Ltd. (Formulations Division, Unit-II) in Rangareddy District, Telangana, India, identified a significant concern regarding the manufacturing process. The firm failed to establish appropriate time limits and other critical parameters for production equipment during equipment qualification. This deficiency impacts the assurance of drug product quality.

## Related Documents

- [483 - 2019-11-15](https://www.globalkeysolutions.net/records/483/msn-laboratories-private-limited-formulations-division-unit-ii/5e02b94b-31c4-4b4f-9a3a-1ab95cb9f334)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.globalkeysolutions.net/companies/msn-laboratories-private-limited-formulations-division-unit-ii/44914049-4b84-4bac-abac-9af09a223eb8

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1