Inspection Record

Suzhou Suncadia Biopharmaceuticals Co., Ltd. — FDA 483 Findings

US FDAInspected 2025-01-06Published 2025-05-23 3 findingsAseptic processing and sterility assuranceOther quality systemEquipment and facility

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

Findings

1Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not fully established or followed.

2Other quality system

Appropriate visual inspection (VI) procedures designed to assure drug product quality are not fully established.

3Equipment and facility

Automatic or electronic equipment, including ccmputers or related systems, are not routinely calibrated, inspected, or checked according to written programs designed to assure proper performance.

About this record

Extracted automatically from the document US FDA published on 2025-05-23. 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.

Suzhou Suncadia Biopharmaceuticals Co., Ltd. company profile — full history US FDA documents, 2025 Go to Findings search