Inspection Record

Zhejiang Bangli Medical Products Co. — FDA 483 Findings

US FDAInspected 2016-08-17Published 2017-07-07 7 findingsLabeling and packagingOther quality systemTraining and personnelEquipment and facilityProcess validationDocumentation and records

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

Findings

1Labeling and packaging

There is no practice of labeling APIs.

2Other quality system

Drug products are manufactured in insanitary conditions.

3Training and personnel

Training practices are inadequate.

4Equipment and facility

Manufacturing equipment is not maintained appropriately.

5Other quality system

Distribution procedures are inadequate.

6Process validation

In-Process controls are inadequate.

7Documentation and records

Batch records were not made available for review.

About this record

Extracted automatically from the document US FDA published on 2017-07-07. 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 Bangli Medical Products Co. company profile — full history US FDA documents, 2017 Go to Findings search