1Other quality system
Records not made readily available during an FDA inspection.
Inspection Record
Cipla Ltd. Virgonagar Site — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Process validations ofAPI intermediates are not designed and executed in a manner consistent with the original change control proposals, using all equipment specified in the change control.
3Material and supplier control
Preventative controls over your electronic inventory and warehousing management systems are not effectively established to prevent product mix-ups and ensure traceability for the life cycle of the material.
4Labeling and packaging
Written procedures for packaging operations are not established.
5Documentation and records
Stability studies performed to determine the expiry dates for finished APIs are not conducted in the same container closure system as the packaging procedure specified in the batch records.
About this record
Extracted automatically from the document US FDA published on 2019-07-30. 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.
