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
Teva Pharmaceutical Works Private Limited Company — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
An()(4) -Field Alert Report was not submitted within three working days ofreceipt of information concerning bacteriological contamination in a distributed drug product.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Laboratory and QC controls
The accuracy, sensitivity, specificity, and reproducibility oftest methods have not been established.
5Documentation and records
Procedures for the preparation ofmaster production and control records are not followed.
6Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
7Material and supplier control
Reports ofanalysis from component suppliers are accepted in lieu oftesting each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation ofthe supplier's test results at appropriate intervals.
8Equipment and facility
Buildings used in the manufacturing of a drug product are not maintained in a good state of repair.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include adequate validation of the sterilization process.
10Computer 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.
11Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established and followed.
About this record
Extracted automatically from the document US FDA published on 2016-11-29. 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.
