Inspection Record

Fairview Compounding Pharmacy — FDA 483 Findings

US FDAInspected 2018-08-02Published 2020-02-03 5 findingsAseptic processing and sterility assuranceValidation and qualificationContamination control

Inspectors Anthony J Ladner · Tenzin JangchupThe 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

The use of sporicidal agents in the cleanrooms and ISO 5 classified aseptic processing area was inadequate.

2Validation and qualification

ISO 5 classified areas were not certified under dynamic conditions.

3Aseptic processing and sterility assurance

Biological indicators were not used to verify the adequacy of the sterilization cycle.

4Contamination control

Personnel did not disinfect and change gloves frequently enough to prevent contamination.

5Aseptic processing and sterility assurance

Non-sterilized and Non-depyrogenated equipment was used in sterile drug production.

About this record

Extracted automatically from the document US FDA published on 2020-02-03. 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.

Fairview Compounding Pharmacy company profile — full history US FDA documents, 2020 Go to Findings search