Inspection Record

Mayo Clinic Pharmacy — FDA 483 Findings

US FDAInspected 2018-08-15Published 2019-04-30 5 findingsAseptic processing and sterility assuranceContamination controlOther quality system

Inspectors Tenzin Jangchup · James K IrelandThe 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

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.

2Contamination control

Non-microbial contamination was observed in your production area.

3Other quality system

Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were insufficient to achieve adequate levels of disinfection.

4Aseptic processing and sterility assurance

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

5Aseptic processing and sterility assurance

No endotoxin testings are done for multi-dose products which are not produced with a preservative to ensure product sterility.

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.

Mayo Clinic Pharmacy company profile — full history US FDA documents, 2019 Go to Findings search