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
Inspectors Rita K Kabaso · Nancy M EspinalThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
3Material and supplier control
Establishment of the reliability of the component supplier's repo1i of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
4Quality unit oversight
The responsibilities and procedmes applicable to the quality control unit are not in writing and fully followed.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diug products purpo1iing to be sterile did not include adequate validation of the aseptic and sterilization process.
6Laboratory and QC controls
The accuracy, specificity and reproducibility of test methods have not been established and documented.
7Contamination control
The control systems necessaiy to prevent contamination or mix-ups are deficient.
About this record
Extracted automatically from the document US FDA published on 2021-12-06. 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.
