# FDA 483 - Alembic Pharmaceuticals Limited - August 30, 2022

Source: https://www.keypedia.com/records/483/alembic-pharmaceuticals-limited/ec07c909-af00-4f98-8c1e-5b31d2cd34dc

> FDA 483 for Alembic Pharmaceuticals Limited on August 30, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alembic Pharmaceuticals Limited
- Inspection Date: 2022-08-30
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Alembic Pharmaceuticals Limited, a sterile pharmaceutical manufacturer in Vadodara, Gujarat, revealed deficiencies in aseptic processing areas, specifically regarding airflow visualization studies. Additionally, the firm failed to adequately record and justify deviations from written production and process control procedures, with several investigations lacking appropriate preventative actions.

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## Related Officers

- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

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