1Stability and storage
Results of stability testing are not used in dete1mining.
Inspection Record
Intas Pharmaceuticals Ltd. — FDA 483 Findings
Inspectors Justin A Boyd · Pratik S Upadhyay · 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
2Deviation, CAPA, and investigation
Investigations ofa failure ofa batch or any of its components to meet any of its specifications did not extend to other diug products that may have been associated with the specific failure or discrepancy.
3Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
4Computer system validation
Appropriate conu-ols ru.·e not exercised over computers or related systems to assure that changes in master production and conti·ol records or other records are instituted only by authorized personnel.
5Laboratory and QC controls
Established test procedures and laborato1y control mechanisms are not followed.
6Process validation
Your fnm failed to establish adequate written procedures for production and process controls designed to assure that the diug products have the identity, strength, purity, and quality that they are purpo1ted or represented to possess.
7Laboratory and QC controls
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of mug products pmpo1t ing to be sterile are not established and followed.
9Other 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.
10Aseptic processing and sterility assurance
Aseptic processing ai·eas are deficient regarding the system for monitoring environmental conditions.
11Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been ah-eady distributed.
About this record
Extracted automatically from the document US FDA published on 2023-01-18. 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.
