Prompt Praxis Laboratories LLCAugust 22, 2025

FDA 483 - Prompt Praxis Laboratories LLC - August 22, 2025

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Record Details

Prompt Praxis Laboratories LLC in Vernon Hills, IL, received a Form 483 for failing to fully follow its quality control unit procedures. The firm did not adhere to its standard operating procedure for evaluating aberrant results, specifically by not closing Laboratory Investigation Reports (LIRs) in a timely manner. This indicates a lapse in the timely resolution of quality-related investigations.

Company: Prompt Praxis Laboratories LLC
Inspection Date: August 22, 2025
Product Type: Drugs
Office: Chicago District Office
Person: Darren S. Brown (Consumer Safety Officer)

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ID · 43438049-363b-4aa4-8bab-ee94e1b34ff2