# FDA 483 - Laurus Labs Limited - June 14, 2019

Source: https://www.globalkeysolutions.net/records/483/laurus-labs-limited/561ad5c6-ede4-4617-835c-81b6b1ac8955

> FDA 483 for Laurus Labs Limited on June 14, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laurus Labs Limited
- Inspection Date: 2019-06-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Laurus Labs Limited, an Active Pharmaceutical Ingredient manufacturer in Parwada, India, was cited for two significant issues during an FDA inspection. The firm failed to adequately document preventative and corrective actions for various investigations and lacked complete records for API labeling. These observations indicate deficiencies in quality system documentation and record-keeping practices.

## Related Documents

- [483 - 2017-08-18](https://www.globalkeysolutions.net/records/483/laurus-labs-limited/6622e44c-e7ad-4666-980f-503a2301baba)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/nije-a-thomas/3d1ede3c-d04e-4c2e-a9a8-61261f4d44b5)
- [Jennifer L. Huntington](https://www.globalkeysolutions.net/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.globalkeysolutions.net/companies/laurus-labs-limited/de6ba41e-9c9b-4d3d-bd7a-ccbc275c080d

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