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

Source: https://www.keypedia.com/records/483/alembic-pharmaceuticals-limited/f9f7f10d-6f7d-44d0-a2e9-ca84399aed37

> 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 Biological Products Operations - Division I
- Summary: An FDA inspection of Alembic Pharmaceuticals Limited, a sterile pharmaceutical manufacturer in Vadodara, Gujarat, India, revealed two significant observations. The firm's aseptic processing areas were found to have deficient air supply due to inadequate airflow visualization studies. Additionally, the company failed to properly record and justify deviations from written procedures, with multiple investigations lacking appropriate preventative actions to prevent reoccurrence.

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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-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1