# FDA 483 - Laurus Labs Limited (Unit-5) - October 28, 2022

Source: https://www.keypedia.com/records/483/laurus-labs-limited-unit-5/e077f27e-e6e9-430b-93a3-b8b529bf8eb7

> FDA 483 for Laurus Labs Limited (Unit-5) on October 28, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laurus Labs Limited (Unit-5)
- Inspection Date: 2022-10-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: During an inspection of Laurus Labs Limited, Unit-5 in Anakapalli, India, the FDA observed a significant deficiency related to facility conditions. Specifically, the firm failed to provide adequate lighting in a critical solvent dispensing area used for intermediate and API manufacturing. This issue could impact the safety and quality of pharmaceutical production.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/nadeem-i-chaudhry/7d867939-2dc6-4503-b9b9-6f26b16c347e)

Company: https://www.keypedia.com/companies/laurus-labs-limited-unit-5/a620e1c4-4dd0-47fa-9914-85f2a6eb10e7

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