Inspection Record

Dolan Central Illinois Compounding LLC dba Preckshot Professional — FDA 483 Findings

US FDAInspected 2018-08-10Published 2019-04-30 5 findingsAseptic processing and sterility assuranceOther quality systemEquipment and facility

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

1Aseptic processing and sterility assurance

Equipment was not disinfected prior to entering the aseptic processing areas.

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.

Dolan Central Illinois Compounding LLC dba Preckshot Professional company profile — full history US FDA documents, 2019 Go to Findings search