1Process validation
Written production and process control procedures are not followed in the execution ofproduction and process control functions and documented at the time of performance.
Inspection Record
Dr. Reddy's Laboratories Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
3Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
4Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test .
About this record
Extracted automatically from the document US FDA published on 2019-02-26. 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.
