1Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Inspection Record
Dr. Reddy's Laboratories Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug ~ product.
3Quality unit oversight
The quality control unit lacks authority to fully investigate errors that have occurred.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile did not include adequate validation ofthe sterilization process.
5Material and supplier control
Each lot of a component, drug product container and closure that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.
6Deviation, CAPA, and investigation
Deviations from written production and process control procedures are notjustified.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
8Equipment and facility
Equipment for adequate contro!
About this record
Extracted automatically from the document US FDA published on 2019-08-29. 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.
