# FDA 483 - Amneal Pharmaceuticals Private - May 12, 2025

Source: https://www.keypedia.com/records/483/amneal-pharmaceuticals-private/c70ee925-15e6-410e-aa37-5aa316352e1d

> FDA 483 for Amneal Pharmaceuticals Private on May 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amneal Pharmaceuticals Private
- Inspection Date: 2025-05-12
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Amneal Pharmaceuticals Private in Ahmedabad, India, received a Form 483 with two observations following an FDA inspection. The firm was cited for inadequate control procedures related to manufacturing processes, specifically failing to properly qualify a sterile injection filling machine, which resulted in uncontrolled fill weight variability. Additionally, the inspection revealed a lack of established procedures to prevent microbiological contamination, including deficiencies in personnel monitoring and dynamic airflow visualization studies in classified cleanroom areas.

## Related Officers

- [Investigator](https://www.keypedia.com/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)

Company: https://www.keypedia.com/companies/amneal-pharmaceuticals-private/56032239-f02d-481f-bd06-31fc4601b2f9

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3