1Aseptic processing and sterility assurance
Equipment was not disinfected prior to entering the aseptic processing areas.
Inspection Record
Dolan Central Illinois Compounding LLC dba Preckshot Professional — FDA 483 Findings
Inspectors Bei Y HeThe 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
Your firm prepares multi-dose sterile drug products with an extended beyond use date without preservatives.
3Aseptic processing and sterility assurance
Disinfecting agents and cleaning pads used in the ISO 5 classified aseptic processing areas were not sterile.
4Other quality system
Non-sterile bulk solutions are held for an extended period with no documentation to support the hold time.
5Equipment and facility
Your facility was designed and/or operated in a way that permits poor flow of materials.
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.
