1Documentation and records
The results of the examination of the packaged and labeled products were not documented in the batch production or control records.
Inspection Record
Pharmakon Pharmaceuticals — 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 ri.ot the batch has been already distributed.
3Process validation
Written production and process control procedures are not followed in the execution of production and process control functions.
4Documentation and records
Examination of packaging and labeling materials for suitability and correctness before packaging operations is not performed and not documented in the batch production records.
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.
