1Equipment and facility
Failure to have the procedures and processes necessary to ensure the API and intermediates manufactured at your facility meet established specifications for quality and purity.
Inspection Record
Centrient Pharmaceuticals India Private Limited — FDA 483 Findings
Inspectors Pratik S. UpadhyayThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Failure of production operations to prevent contamination of intermediate and API by other materials.
3Cleaning validation
Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the intermediates and Active Pharmaceutical Ingredient beyond the official or other established specifications.
About this record
Extracted automatically from the document US FDA published on 2026-10-19. 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.
