Inspection Record

Denver Solutions, LLC dba Leiter's Health — FDA 483 Findings

US FDAInspected 2018-11-15Published 2024-01-17 4 findingsAseptic processing and sterility assuranceDeviation, CAPA, and investigationLaboratory and QC controls

Inspectors Nicholas L HuntThe inspectors who signed the published document.Inspector lookup

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

Findings

1Aseptic processing and sterility assurance

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

2Deviation, CAPA, and investigation

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

3Laboratory and QC controls

Drug products failing to meet established quality control criteria are not rejected.

4Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. 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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