# FDA 483 - Amneal Pharmaceuticals Private Limited - May 02, 2023

Source: https://www.keypedia.com/records/483/amneal-pharmaceuticals-private-limited/2987eff4-fdf3-47b8-9930-1a278737dbab

> FDA 483 for Amneal Pharmaceuticals Private Limited on May 02, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amneal Pharmaceuticals Private Limited
- Inspection Date: 2023-05-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Puniska Healthcare Private Limited, a sterile drug manufacturer in Pipan, Gujarat, received a Form 483 with two observations. The inspection revealed deficiencies in written quality control procedures for packaging operations and inadequate laboratory controls regarding the stability of solutions used in testing. These issues indicate a lack of robust systems to ensure drug product quality and integrity.

## Related Officers

- [Jose F. Velez](https://www.keypedia.com/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)

Company: https://www.keypedia.com/companies/amneal-pharmaceuticals-private-limited/fdb45026-a932-4f88-ba8b-0acbd3beee98

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