# FDA 483 - Elysium Pharmaceuticals Limited - January 16, 2023

Source: https://www.keypedia.com/records/483/elysium-pharmaceuticals-limited/d3c9a254-7ccd-4b13-b5e1-b296f0d7a521

> FDA 483 for Elysium Pharmaceuticals Limited on January 16, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elysium Pharmaceuticals Limited
- Inspection Date: 2023-01-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Elysium Pharmaceuticals Limited in Vadodara, India, revealed significant deficiencies across laboratory controls, facility maintenance, and production record-keeping. Observations included unrecorded deviations from test procedures, incomplete laboratory data, water system leaks, inadequate equipment cleaning, and missing documentation of personnel actions in batch records. These issues indicate a lack of adherence to good manufacturing practices.

## Related Officers

- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)
- [Consumer Safety Officer (Drug Specialist)](https://www.keypedia.com/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

Company: https://www.keypedia.com/companies/elysium-pharmaceuticals-limited/6249fc41-1206-431f-87ee-b7b13c89e8f4

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