# FDA 483 - Alembic Pharmaceuticals Limited - March 24, 2023

Source: https://www.keypedia.com/records/483/alembic-pharmaceuticals-limited/eddad71e-1e59-406b-931a-d1dd1cedbd0a

> FDA 483 for Alembic Pharmaceuticals Limited on March 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alembic Pharmaceuticals Limited
- Inspection Date: 2023-03-24
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Alembic Pharmaceuticals Limited in Vadodara, India, a sterile drug manufacturer, received a Form 483 with two observations. The inspection revealed inadequate quality control unit oversight regarding batch record review for drug product release and deficiencies in the internal audit system. These issues indicate a lack of robust quality management practices.

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## Related Officers

- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.keypedia.com/companies/alembic-pharmaceuticals-limited/bcd367a1-cf84-4cfe-9105-9e655cde13dc

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