1Other quality system
Design plans that describe or reference the design and development activities and define responsibility for implementation have not been adequately established.
Inspection Record
Sun Pharmaceutical Industries Ltd. — 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 drug products purporting to be sterile are not followed.
3Other quality system
A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
4Laboratory and QC controls
Established laboratory control mechanisms are not documented at the time of performance.
About this record
Extracted automatically from the document US FDA published on 2019-06-21. 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.
