Inspection Record

Fukuzyu Pharmaceutical Co., Ltd. — FDA 483 Findings

US FDAInspected 2024-01-19Published 2026-03-03 4 findingsValidation and qualificationEquipment and facilityData integrityDeviation, CAPA, and investigation

Inspectors Nicholas L. HuntThe inspectors who signed the published document.Inspector lookup

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

Findings

1Validation and qualification

Validation of analytical methods is incomplete.

2Equipment and facility

Shared production equipment is not always cleaned and maintained in a manner suitable to prevent cross­ contamination of non-hazardous API by hazardous substances.

3Data integrity

Appropriate procedures are not established and followed for control ofcomputerized systems and electronic records in the QC laboratory.

4Deviation, CAPA, and investigation

The quality unit does not always conduct thorough investigations for out-of-specification results and critical deviations.

About this record

Extracted automatically from the document US FDA published on 2026-03-03. 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.

Fukuzyu Pharmaceutical Co., Ltd. company profile — full history US FDA documents, 2026 Go to Findings search