1Validation and qualification
ISO 5 Areas are not certified under dynamic conditions.
Inspection Record
Roger Williams Medical Center — FDA 483 Findings
Inspectors Jonathan G Matrisciano · Jonah S UfferfilgeThe 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
Your facility design allowed the influx of poor quality air into a higher classified area.
3Aseptic processing and sterility assurance
The use of sporicidal agents in the cleamooms and ISO 5 classified aseptic processing area was inadequate.
4Equipment and facility
The ISO 7 classified areas have difficult to clean, particle -generating equipment or surfaces.
5Aseptic 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.
6Equipment and facility
Your facility was designed and/or operated in a way that permits poor flow of personnel.
7Aseptic processing and sterility assurance
Disinfecting agents and cleaning pads used in the ISO 5 classified aseptic processing areas were not sterile.
About this record
Extracted automatically from the document US FDA published on 2019-11-05. 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.
