Inspection Record

UBI Pharma Inc. — FDA 483 Findings

US FDAInspected 2025-10-14Published 2025-12-18 5 findingsDeviation, CAPA, and investigationQuality unit oversightEquipment and facilityAseptic processing and sterility assuranceMaterial and supplier control

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

Findings

1Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any ofits specifications whether or not the batch has been already distributed.

2Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not in writing and /or fully followed.

3Equipment and facility

Equipment used in the manufacture, processing, packing or holding of diug products is not of appropriate design to facilitate operations for its intended use.

4Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of diug products purpo1iing to be sterile are not established and/or followed.

5Material and supplier control

Control procedures are not established which monitor the output and validate the perfo1mance ofthose manufachlring processes that may be responsible for causing variability in the characteristics of in process material and the diug product.

About this record

Extracted automatically from the document US FDA published on 2025-12-18. 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.

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