Inspection Record

Joe Wise Pharmacy, Inc. dba Wise Pharmacy — FDA 483 Findings

US FDAInspected 2019-06-21Published 2019-08-21 4 findingsMaterial and supplier controlContamination controlValidation and qualificationAseptic processing and sterility assurance

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

Findings

1Material and supplier control

You used a non-pharmaceutical grade component in the formulation of a drug product.

2Contamination control

You produced hazardous drugs without providing adequate containment and cleaning of work surfaces to prevent cross-contamination.

3Validation and qualification

ISO 5 classified areas were not certified under dynamic conditions.

4Aseptic processing and sterility assurance

Environmental monitoring was not perfomJed in your aseptic processing areas.

About this record

Extracted automatically from the document US FDA published on 2019-08-21. 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

2021-04-27 · US FDA · 5 findings
Joe Wise Pharmacy, Inc. dba Wise Pharmacy company profile — full history US FDA documents, 2019 Go to Findings search