1Aseptic processing and sterility assurance
Procedmes designed to prevent microbiological contamination of diug products pmporting to be sterile are not established, written and followed.
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
2Equipment and facility
Buildings used in the manufacture, processing, packing or holding of drng products are not maintained in a clean and sanitaiy condition.
3Laboratory and QC controls
Established test procedures are not documented at the time ofperfo1m ance.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
6Laboratory and QC controls
The written stability program for drng products does not include meaningful test methods.
7Other quality system
Laborato1y records do not include complete data derived from all tests, examinations and assay necessa1y to assure compliance with established specifications and standards.
8Quality unit oversight
Changes to written procedures are not reviewed and approved by the quality control unit.
9Documentation and records
Batch production and control records do not include complete infonnation relating to the production and control of each batch.
10Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drng products purpo1iing to be sterile did not include adequate validation of the aseptic process.
11Material and supplier control
Dmg product component testing is deficient in that at least one specific test to verify the identity of each component is not perfonned.
About this record
Extracted automatically from the document US FDA published on 2023-11-29. 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.
