1Aseptic processing and sterility assurance
You did not take remedial action where actionable microbial contamination was found to be present in the ISO 5 classified aseptic processing area during aseptic production.
Inspection Record
Pharmcore Inc. dba Hallandale Pharmacy — FDA 483 Findings
Inspectors Patty P KaewussdangkulThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
3Cleaning validation
Cleaning procedures are inadequate to prevent cross contamination.
About this record
Extracted automatically from the document US FDA published on 2021-11-19. 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.
