# FDA 483 - Alembic Pharmaceuticals Limited - December 16, 2022

Source: https://www.globalkeysolutions.net/records/483/alembic-pharmaceuticals-limited/4a94c328-8b9f-47b5-b129-9d9a0c6f27e8

> FDA 483 for Alembic Pharmaceuticals Limited on December 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alembic Pharmaceuticals Limited
- Inspection Date: 2022-12-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Alembic Pharmaceuticals Limited, a non-sterile drug manufacturer in Vadodara, India, was cited for significant deficiencies across multiple areas during an FDA inspection. Observations included inadequate equipment cleaning and maintenance, lack of procedures to prevent objectionable microorganisms, and failures in production and process controls. The firm also demonstrated deficiencies in environmental monitoring and a systemic failure to follow deviation management procedures for critical equipment breakdowns.

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## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/alembic-pharmaceuticals-limited/312ff75c-8a88-40fe-a7a6-52fa52c791cb

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1