1Laboratory and QC controls
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
Inspection Record
Cohance Lifesciences Limited — FDA 483 Findings
Inspectors Guerlain UlysseThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
Written records of investigation of a diug complaint do not include the follow-up.
3Equipment and facility
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a diu g product.
4Equipment and facility
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the diug product.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
6Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been ah-eady distributed.
About this record
Extracted automatically from the document US FDA published on 2025-09-22. 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.
