1Aseptic processing and sterility assurance
Aseptic processing area are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Aurobindo Pharma Ltd. Unit-XII — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Buildings used in the manufacturing, processing, packing, and holding ofa drug product are not maintained in a good state of repair.
3Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
4Process validation
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any ofits components to meet any of its specifications whether or not the batch has been already distributed.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed, or did not include adequate validation ofthe aseptic process.
7Equipment and facility
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
About this record
Extracted automatically from the document US FDA published on 2025-10-03. 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.
