1Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Inspection Record
Cipla Limited — FDA 483 Findings
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 diu g products pmpo1ting to be sterile did not include adequate validation of the aseptic process.
3Equipment and facility
Procedures for the cleaning and maintenance of equipment ai·e deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
5Other quality system
The responsibilities and procedures applicable to the quality conti·ol unit are not in writing and fully followed.
6Aseptic processing and sterility assurance
Aseptic processing areas ai·e deficient regarding the system for cleaning and disinfecting the to produce aseptic conditions.
About this record
Extracted automatically from the document US FDA published on 2022-09-21. 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.
