# FDA 483 - Laurus Labs Limited - February 10, 2023

Source: https://www.keypedia.com/records/483/laurus-labs-limited/f55e9f9f-df26-4af2-a33e-4e838000303c

> FDA 483 for Laurus Labs Limited on February 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laurus Labs Limited
- Inspection Date: 2023-02-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Laurus Labs Limited in Visakhapatnam, India, revealed two significant observations. The firm failed to maintain its manufacturing buildings in a clean and sanitary condition, evidenced by black discoloration on a HEPA filter. Additionally, the company did not thoroughly investigate unexplained discrepancies and out-of-specification results related to impurity contamination in drug products during stability studies.

## Related Officers

- [Dennis Cantellops Paite](https://www.keypedia.com/people/dennis-cantellops-paite/3336bbb8-8520-4a8a-9085-76e7a55ca773)
- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.keypedia.com/companies/laurus-labs-limited/4112e7fd-7d8d-41bc-914f-6c705b2e47c7

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