Inspection Record

Zhejiang Hisun Pharmaceuticals — FDA 483 Findings

US FDAInspected 2017-08-11Published 2022-03-29 4 findingsProcess validationEquipment and facilityLaboratory and QC controlsStability and storage

Inspectors Peter E. Baker · Parul Patel · Parul PaidThe inspectors who signed the published document.Inspector lookup

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

Findings

1Process validation

Process validation studies do not contain a history ofall relevant data.

2Equipment and facility

Written procedures are deficient regarding the cleaning and maintenance of equipment.

3Laboratory and QC controls

Laboratory records do not include complete data derived from microbial limit testing to ensure established procedures are followed.

4Stability and storage

Storage conditions for samples retained for testing are not monitored appropriately.

About this record

Extracted automatically from the document US FDA published on 2022-03-29. 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 Hisun Pharmaceuticals company profile — full history US FDA documents, 2022 Go to Findings search