Inspection Record

Denver Solutions, LLC OBA Leiters Health — FDA 483 Findings

US FDAInspected 2021-10-07Published 2022-02-18 7 findingsLaboratory and QC controlsDeviation, CAPA, and investigationMaterial and supplier controlAseptic processing and sterility assurance

Inspectors Michael A Charles · Alan P KurtzbergThe inspectors who signed the published document.Inspector lookup

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Findings

1Laboratory and QC controls

Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

2Deviation, CAPA, and investigation

Deviations from written production and process control procedures are not recorded.

3Material and supplier control

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected components, drug product containers, closures and labeling before disposition.

4Aseptic processing and sterility assurance

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

5Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding air supply that is <Redacted B4> through high-efficiency <Redacted B4> to <Redacted B4> under positive pressure.

6Deviation, CAPA, and investigation

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

7Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.

About this record

Extracted automatically from the document US FDA published on 2022-02-18. 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.

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