1Aseptic processing and sterility assurance
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
Inspection Record
Kings Park Slope Inc — FDA 483 Findings
Inspectors Rachael A MoliverThe 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
The use of sporicidal agents in the ISO 5 classified aseptic processing area was inadequate.
3Equipment and facility
Your facility design allowed the influx o fpoor quality air into a higher classified area.
4Aseptic processing and sterility assurance
Media fills were not performed that closely simulate aseptic production operations incorporating as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. 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.
