1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
MedPark Pharmacy — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
3Aseptic processing and sterility assurance
Drug product containers shall b e clean, where indicated by the nature of the drug, sterilized a nd processed to remove pyrogenic properties to assure that they are suitable for their intended use.
4Laboratory and QC controls
Testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory conformance to final specifications and identity and strength of each active ingredient prior to release.
5Laboratory and QC controls
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
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.
