1Laboratory and QC controls
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Inspection Record
Cipla Limited — FDA 483 Findings
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.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
4Computer 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.
5Material and supplier control
There is a failure to thoroughly review 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.
6Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
About this record
Extracted automatically from the document US FDA published on 2024-06-26. 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.
