1Process validation
Written production and process control procedures are not followed in the execution of production and process control functions.
Inspection Record
Meridian Medical Technologies a Pfizer Company — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
3Quality unit oversight
The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
4Complaint and recall handling
An NDA-Field Alert Report was not submitted within three working days ofreceipt of information concerninga failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
5Documentation and records
Batch production and control records do not include complete information relating to the production and control of each , batch.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
