Inspection Record

ImprimisRx CA Inc. dba ImprimisRx — FDA 483 Findings

US FDAInspected 2017-04-24Published 2024-01-17 3 findingsAseptic processing and sterility assuranceComplaint and recall handlingQuality unit oversight

View the regulator's official source The source document is always the basis for judgement.

Findings

1Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.

2Complaint and recall handling

Complaint records are deficient in that they do not include the findings of the investigation and follow up.

3Quality unit oversight

The quality control unit lacks authority to fully investigate errors that have occurred.

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.

ImprimisRx CA Inc. dba ImprimisRx company profile — full history US FDA documents, 2024 Go to Findings search