Inspection Record

Second Tokushima Factory, Otsuka Pharmaceutical Co. Ltd. — FDA 483 Findings

US FDAInspected 2024-03-22Published 2024-08-30 5 findingsMaterial and supplier controlDeviation, CAPA, and investigationAseptic processing and sterility assuranceEquipment and facility

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

Findings

1Material and supplier control

Repo1is of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without peifo1ming at least one specific identity test on each component.

2Deviation, CAPA, and investigation

Deviations from written sampling plans ai·e not justified.

3Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

4Equipment and facility

Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drng product.

5Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been aheady distributed.

About this record

Extracted automatically from the document US FDA published on 2024-08-30. 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.

Second Tokushima Factory, Otsuka Pharmaceutical Co. Ltd. company profile — full history US FDA documents, 2024 Go to Findings search