1Material and supplier control
Dete1minations of confo1mance to appropriate written specifications for acceptance are deficient for in- process materials.
Inspection Record
Indoco Remedies Limited — FDA 483 Findings
Inspectors Saleem A AkhtarThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be sterile are not established and followed.
5Complaint and recall handling
Procedmes describing the handling of written and oral complaints related to diug products are deficiently written or followed.
About this record
Extracted automatically from the document US FDA published on 2025-03-06. 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.
