Inspection Record

Kyowa Hakko Bio Co., Ltd. — FDA 483 Findings

US FDAInspected 2022-04-15Published 2025-03-06 3 findingsOther quality systemMaterial and supplier controlLaboratory and QC controls

Inspectors Teresa I. NavasThe inspectors who signed the published document.Inspector lookup

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

Findings

1Other quality system

Production System: Your procedures do not classify alarms that are observed in DCS S)' stem (process monitoring system) thus.

2Material and supplier control

Materials System Your firm does not have evidence to demonstrate that the current monitoring frequency and specifications for water (PFW) used in the manufacture ofAPis ensure the water is suitable for its intended use.

3Laboratory and QC controls

Your finn laboratory controls procedures are inadequate.

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.

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