Inspection Record

Johnson Memorial Cancer Center — FDA 483 Findings

US FDAInspected 2018-10-19Published 2019-04-30 6 findingsAseptic processing and sterility assuranceEquipment and facility

Inspectors Erik W Koester · John P MistlerThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Aseptic processing and sterility assurance

Personnel moved rapidly in the vicinity of open sterile units and instruments, which disrupted the airflow and increased the risk of bringing lesser quality air into the ISO 5 classified aseptic processing area.

2Aseptic 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 an area adjacent to the ISO 5 classified aseptic processing area during aseptic production.

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.

5Aseptic processing and sterility assurance

Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.

6Aseptic processing and sterility assurance

You had inadequate HEP A filter coverage and airflow over the area to which sterile product was exposed.

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.

Other records for this company

2015-07-23 · US FDA · 5 findings2021-10-21 · US FDA · 4 findings
Johnson Memorial Cancer Center findings history — including this company's other documents US FDA documents, 2019 Go to Findings search