# FDA 483 - Unichem Laboratories Limited - July 31, 2019

Source: https://www.keypedia.com/records/483/unichem-laboratories-limited/3000e25f-9a9c-4699-8db5-1d064d2276fd

> FDA 483 for Unichem Laboratories Limited on July 31, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unichem Laboratories Limited
- Inspection Date: 2019-07-31
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Unichem Laboratories Limited in Bardez, Goa, India, was inspected by the FDA from July 22-31, 2019. The inspection revealed significant deficiencies across manufacturing process controls, data integrity, sanitation practices, and computer system security. Issues included a lack of validated manufacturing processes, inadequate data backup procedures, failure to follow written sanitation SOPs, and unauthorized changes to critical system setpoints.

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## Related Officers

- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

Company: https://www.keypedia.com/companies/unichem-laboratories-limited/2b8c7905-52a2-4b2e-a97e-0a1d5b2d88ea

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