1Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Inspection Record
MedisourceRx — FDA 483 Findings
Inspectors Liming ZhangThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
3Equipment and facility
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed.
5Documentation and records
The master production and control records are deficient in that they do not include complete manufacturing, control, instructions, testing and specifications.
6Process validation
Written production and process control procedures are not documented at the time of performance.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contarnination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
About this record
Extracted automatically from the document US FDA published on 2025-03-11. 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.
