Inspection Record

Valgene Incorporated dba Cape Drugs — FDA 483 Findings

US FDAInspected 2021-12-02Published 2022-03-09 4 findingsEquipment and facilityValidation and qualificationAseptic processing and sterility assuranceOther quality system

Inspectors Sena G Dissmeyer · Kathleen M JordanThe 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 design allowed the influx of poor quality air into a higher classified area.

2Validation and qualification

ISO 5 classified areas were not certified under dynamic conditions.

3Aseptic processing and sterility assurance

The ISO 5 classified aseptic processing areas had difficult to clean and particle-generating equipment or surface.

4Other 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.

About this record

Extracted automatically from the document US FDA published on 2022-03-09. 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.

Valgene Incorporated dba Cape Drugs company profile — full history US FDA documents, 2022 Go to Findings search