Inspection Record

Sumitomo Pharma Co., Ltd. — FDA 483 Findings

US FDAInspected 2025-08-07Published 2025-10-24 3 findingsComputer system validationContamination controlOther quality system

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

Findings

1Computer system validation

Failure to maintain a backup file of data entered into the computer or related system.

2Contamination control

Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed.

3Other quality system

The number of containers to be sampled is not based upon appropriate criteria.

About this record

Extracted automatically from the document US FDA published on 2025-10-24. 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.

Sumitomo Pharma Co., Ltd. company profile — full history US FDA documents, 2025 Go to Findings search