# FDA 483 - MSN Laboratories Private Limited (Formulations Division, Unit-II) - November 15, 2019

Source: https://www.globalkeysolutions.net/records/483/msn-laboratories-private-limited-formulations-division-unit-ii/5e02b94b-31c4-4b4f-9a3a-1ab95cb9f334

> FDA 483 for MSN Laboratories Private Limited (Formulations Division, Unit-II) on November 15, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: MSN Laboratories Private Limited (Formulations Division, Unit-II)
- Inspection Date: 2019-11-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of MSN Laboratories Private Limited (Formulations Division, Unit-II) in Rangareddy District, India, revealed significant deficiencies in their manufacturing of human drug products. Observations included inadequate procedures to prevent microbial contamination in sterile products, insufficient cleaning and maintenance of equipment, and inconsistent practices for visual inspection of injectable products. The firm also lacked proper statistical procedures for evaluating reserve samples, indicating a broad range of quality control issues.

## Related Documents

- [483 - 2019-06-20](https://www.globalkeysolutions.net/records/483/msn-laboratories-private-limited-formulations-division-unit-ii/b54c9c76-a591-428d-9e20-8fadbfdd0c09)

## Related Officers

- [Jose A. Cruz Gonzalez](https://www.globalkeysolutions.net/people/jose-a-cruz-gonzalez/a005cff1-0a90-4396-82c4-de4b0a579374)

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