1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Natco Pharma Limited — FDA 483 Findings
Inspectors Arsen Karapetyan · Wayne D McgrathThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the dmg product.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diug products pmpo1iing to be sterile are not established, written and followed.
4Equipment and facility
Buildings used in the manufacture, processing, packing, or holding of a chug product do not have the suitable constmction to facilitate cleaning, maintenance, and proper operations.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of mug products pmpo1ting to be sterile did not include adequate validation of the aseptic process.
6Deviation, 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 2025-07-10. 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.
