Inspection Record

Custom Analytics LLC — FDA 483 Findings

US FDAInspected 2026-03-12Published 2026-07-10 3 findingsContamination controlDeviation, CAPA, and investigationEquipment and facility

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

Findings

1Contamination control

The separate or defined areas necessary to prevent contamination or mix-ups are deficient.

2Deviation, CAPA, and investigation

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

3Equipment and facility

Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.

About this record

Extracted automatically from the document US FDA published on 2026-07-10. 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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