# FDA 483 - Par Formulations Private Limited - April 05, 2022

Source: https://www.globalkeysolutions.net/records/483/par-formulations-private-limited/400bbc4f-1742-4da7-8c2c-262920e13ee5

> FDA 483 for Par Formulations Private Limited on April 05, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Par Formulations Private Limited
- Inspection Date: 2022-04-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Par Formulations Private Limited, a drug manufacturer in Dhar, India, was inspected by the FDA from March 29 to April 5, 2022. The inspection revealed significant deficiencies in equipment cleaning, personnel gowning practices, and laboratory control mechanisms for glassware, indicating potential contamination risks for drug products intended for the US market.

## Related Officers

- [Saleem A. Akhtar](https://www.globalkeysolutions.net/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

Company: https://www.globalkeysolutions.net/companies/par-formulations-private-limited/5f554b68-cd43-4880-b22b-fca02aab50f0

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