FDA 483 - Nutravail, LLC. - February 06, 2020

Nutravail, LLC, a drug manufacturer in Chantilly, VA, was cited for two significant observations during an FDA inspection. The firm failed to exercise appropriate controls over computer systems used for critical analyses, allowing unauthorized changes and inadequate audit trail review. Additionally, the company accepted supplier analyses for components without adequately establishing the reliability of those analyses, leading to the use of out-of-specification materials.