1Equipment and facility
Equipment and utensils are no1 cleaned at appropriate intervals to prevent that would alter the safety, identity, strength, quality or purity ofthe drug product.
Inspection Record
Aurobindo Pharma Limited, Unit VII — FDA 483 Findings
Inspectors Guerlain Ulysse · Nibin VargheseThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Established laboratory control mechanisms are not followed.
3Computer 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.
4Laboratory and QC controls
Laboratory records are deficient in that they do not include a complete record ofall data obtained during testing.
5Complaint and recall handling
Complaints records arc deficient in that they do not include the findings ofthe investigation and follow up.
6Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
7Deviation, 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 already distributed.
8Documentation and records
Master production and control records lack complete manufacturing and control instructions, sampling and testing procedures.
About this record
Extracted automatically from the document US FDA published on 2026-02-20. 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.
