# FDA 483 - Laurus Generics, Inc. - January 21, 2025

Source: https://www.keypedia.com/records/483/laurus-generics-inc/e0a2dac7-8763-4329-867a-18832f9fd8c5

> FDA 483 for Laurus Generics, Inc. on January 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laurus Generics, Inc.
- Inspection Date: 2025-01-21
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Laurus Generics, Inc. in Berkeley Heights, NJ, a corporate office, was inspected by the FDA from January 13-21, 2025. The inspection revealed a significant deficiency related to the firm's pharmacovigilance system. Specifically, the company lacked written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/laurus-generics-inc/0fff81a0-b13d-4317-b3f8-27c76f6f3d42)

## Related Officers

- [Investigator](https://www.keypedia.com/people/jay-b-shah/c437fff9-807e-4dea-80c0-8f77850db6f8)

Company: https://www.keypedia.com/companies/laurus-generics-inc/4f7edb10-6c29-4264-aa22-0ef4aace7266

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248