1Other quality system
The use of apparatus not meeting established specifications was observed.
Inspection Record
Claris Injectables Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.
3Process validation
Written production and process control procedures are not followed in the execution of production and process control functions.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
5Quality unit oversight
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet appropriate statistical quality control criteria as a condition for their approval and release.
About this record
Extracted automatically from the document US FDA published on 2016-11-29. 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.
