Inspection Record

Bushu Pharmaceuticals Ltd. — FDA 483 Findings

US FDAInspected 2022-12-02Published 2025-03-24 3 findingsQuality unit oversightContamination controlLaboratory and QC controls

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

Findings

1Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

2Contamination control

The separate or defined areas and conh'ol systems necessa1y to prevent contamination or mix-ups are deficient.

3Laboratory and QC controls

Established test procedures and laborato1y control mechanisms are not followed and documented at the time ofperfo1mance.

About this record

Extracted automatically from the document US FDA published on 2025-03-24. 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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