1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Cipla Limited — FDA 483 Findings
Inspectors Saleem A Akhtar · Jose E MelendezThe 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
Laborato1y records do not include complete data derived from all tests, examinations and assay necessa1y to assure compliance with established specifications and standards.
3Computer system validation
Appropriate controls ai·e 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.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of mug products pmpo1ting to be sterile are not established, written and followed.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
6Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has been afready distributed.
7Complaint and recall handling
Ant){A) Field Alert Repo1i was not submitted within(ll)<•, pf receipt of info1mation concerning a failure ofone or more distributed batches ofa diug to meet the specifications established for it in the application.
8Complaint and recall handling
Procedmes describing the handling of written and oral complaints related to drng products are deficiently written or followed.
About this record
Extracted automatically from the document US FDA published on 2023-03-02. 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.
