Inspection Record

Fuji Yakuhin Co., Ltd. — FDA 483 Findings

US FDAInspected 2022-11-25Published 2025-03-06 3 findingsEquipment and facilityAseptic processing and sterility assuranceOther quality system

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

Findings

1Equipment and facility

Routine calibration of automatic, mechanical and electronic equipment is not perfo1med according to a written program designed to assme proper perfo1mance.

2Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be sterile are not established, written and followed.

3Other quality system

A sample which is representative ofeach lot in each shipment of each active ingredient is not retained.

About this record

Extracted automatically from the document US FDA published on 2025-03-06. 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.

Fuji Yakuhin Co., Ltd. company profile — full history US FDA documents, 2025 Go to Findings search