Inspection Record

Zhejiang Medicine Co. — FDA 483 Findings

US FDAInspected 2015-06-18Published 2016-12-15 4 findingsEquipment and facilityLaboratory and QC controlsDeviation, CAPA, and investigation

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

Findings

1Equipment and facility

Adequate washing and toilet facilities are not provided.

2Laboratory and QC controls

Laboratory electronic raw data is not controlled and protected.

3Deviation, CAPA, and investigation

Deviations from critical control points are not investigated.

4Equipment and facility

There is no assurance that software used to control critical processing equipment is capable of meeting user requirements for data security.

About this record

Extracted automatically from the document US FDA published on 2016-12-15. 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.

Zhejiang Medicine Co. company profile — full history US FDA documents, 2016 Go to Findings search