# FDA 483 - Laurus Synthesis Private Limited - Unknown Date

Source: https://www.keypedia.com/records/483/laurus-synthesis-private-limited/8b368319-e97e-48ce-adcc-40fe7a9d6bd7

> FDA 483 for Laurus Synthesis Private Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laurus Synthesis Private Limited
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Laurus Synthesis Private Limited, an API Intermediate Manufacturer in Anakapalli, India, revealed significant deficiencies across multiple areas. The firm was cited for inadequate investigations into unexpected occurrences, insufficient sampling plans for intermediates, and poor equipment maintenance and cleaning practices. Additionally, issues were noted with incomplete batch production records and uncontrolled issuance of critical documents, indicating a need for comprehensive quality system improvements.

## Related Documents

- [483 - 2023-12-12](https://www.keypedia.com/records/483/laurus-synthesis-private-limited/c1b44afb-2609-4100-960b-287be6b331e4)

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Investigator](https://www.keypedia.com/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)

Company: https://www.keypedia.com/companies/laurus-synthesis-private-limited/363bc2da-6251-4991-acfd-ff4949afe353

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