# FDA 483 - Alembic Pharmaceuticals Limited (Units I and II) - May 26, 2025

Source: https://www.keypedia.com/records/483/alembic-pharmaceuticals-limited-units-i-and-ii/572804fe-e82a-4cba-8325-58bdcf2ed319

> FDA 483 for Alembic Pharmaceuticals Limited (Units I and II) on May 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alembic Pharmaceuticals Limited (Units I and II)
- Inspection Date: 2025-05-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Alembic Pharmaceuticals Limited (Units I and II) in Halol, Gujarat, India, an API manufacturer, was cited for significant deficiencies across its quality and laboratory control systems. Observations included untimely and inadequate laboratory investigations, unvalidated stability-indicating test procedures, poorly maintained and cleaned equipment, and a lack of Quality Unit oversight on GMP documentation. These issues indicate a systemic failure to ensure the quality and purity of drug substances.

## Related Documents

- [483 - 2025-05-31](https://www.keypedia.com/records/483/alembic-pharmaceuticals-limited-units-i-and-ii/d93249a3-40b4-4a57-b7b3-726eaec789cf)

## Related Officers

- [Pratik S. Upadhyay](https://www.keypedia.com/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

Company: https://www.keypedia.com/companies/alembic-pharmaceuticals-limited-units-i-and-ii/68fd4724-f974-4ddc-8882-a5d28dc90916

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