1Aseptic processing and sterility assurance
The segregated production areas sun ounding the ISO 5 classified aseptic processing area contained dust-collecting overhangs without adequate and frequent cleaning.
Inspection Record
Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy — FDA 483 Findings
Inspectors Marcus F Yambot · Christopher R CzajkaThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Yo ur facility was designed and/or operated in a way that permits poor flow of personnel and materials.
3Aseptic processing and sterility assurance
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was found to be present in the ISO 5 classified aseptic processing area during aseptic production.
4Equipment and facility
Your facility design allowed the influx of poor quality air into a higher classified area.
5Other quality system
HEP A filters were not sealed around each perimeter to the suppori frame.
6Aseptic processing and sterility assurance
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
7Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
About this record
Extracted automatically from the document US FDA published on 2020-02-04. 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.
