1Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
Inspection Record
Kilitch Healthcare India Limited — FDA 483 Findings
Inspectors Anastasia M Shields · Justin A BoydThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
3Quality unit oversight
Changes to written procedures are not reviewed and approved by the quality control unit.
4Laboratory and QC controls
The written stability program for drug products does not include meaningful test methods.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
6Equipment and facility
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
7Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
9Laboratory and QC controls
Established test procedures are not documented at the time of performance.
10Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
11Material and supplier control
Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
About this record
Extracted automatically from the document US FDA published on 2023-11-28. 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.
