Inspection Record

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

US FDAPublished 2024-01-17 5 findingsEquipment and facilityAseptic processing and sterility assuranceOther quality system

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

1Equipment and facility

Your facility was designed and/or operated in a way that permits poor flow of materials.

2Aseptic processing and sterility assurance

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

3Other quality system

Non-sterile bulk solutions are held for an extended period with no documentation to support the hold time.

4Aseptic processing and sterility assurance

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

5Aseptic processing and sterility assurance

Your firm prepares multi-dose sterile drug products with an extended beyond use date without preservatives.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. 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

2024-01-17 · US FDA · 4 findings
Dolan Central Illinois Compounding LLC dba Preckshot Professional Pharmacy findings history — including this company's other documents US FDA documents, 2024 Go to Findings search