1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be sterile are not written.
Inspection Record
Dr. Reddy's Laboratories Limited — FDA 483 Findings
Inspectors Jigar R PatelThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Testing and release ofdrng product for distribution do not include appropriate laborato1y dete1mination of satisfacto1y confo1mance to the final specifications prior to release.
3Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drng products is not of adequate size to facilitate operations for its intended use.
4Material and supplier control
Examination and testing of samples is not done to assure that in-process materials confo1m to specifications.
5Quality unit oversight
Dmg product production and control records, are not reviewed and approved by the quality control unit to dete1mine compliance with all established, approved written procedures before a batch is released or distributed.
6Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been aheady distributed.
About this record
Extracted automatically from the document US FDA published on 2025-08-07. 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.
