# FDA 483 - Alembic Pharmaceuticals Limited - November 10, 2021

Source: https://www.keypedia.com/records/483/alembic-pharmaceuticals-limited/c2f03ec0-cdb4-4891-84ca-6b08b99e6993

> FDA 483 for Alembic Pharmaceuticals Limited on November 10, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alembic Pharmaceuticals Limited
- Inspection Date: 2021-11-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Alembic Pharmaceuticals Limited received a Form 483 citing significant deficiencies in its manufacturing processes for sterile products. Observations included failures in equipment and process validation, inadequate media fill studies, and a lack of thorough investigations into out-of-specification results and non-conformances. The firm also had issues with environmental monitoring, cleaning procedures, quality control unit responsibilities, and computer system controls.

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## Related Officers

- [Yvjina Dezan](https://www.keypedia.com/people/yvjina-dezan/02c97f2b-6443-493a-a0f3-38dc8cf6b4b5)
- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

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