Inspection Record

Laurus Synthesis Private Limited — FDA 483 Findings

US FDAInspected 2023-12-12Published 2023-12-28 5 findingsOther quality systemDeviation, CAPA, and investigationEquipment and facilityDocumentation and records

View the regulator's official source The source document is always the basis for judgement.

Findings

1Other quality system

Sampling plans for intermediates are inadequate.

2Deviation, CAPA, and investigation

Investigation of unexpected occurrences are not adequately conducted.

3Equipment and facility

Equipment is not maintained, cleaned, and stored in a manner to prevent contamination.

4Other quality system

The issuance ofdocuments is not adequately controlled.

5Documentation and records

Batch production records do not contain complete information related to the production and control of the batch.

About this record

Extracted automatically from the document US FDA published on 2023-12-28. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Laurus Synthesis Private Limited company profile — full history US FDA documents, 2023 Go to Findings search