FDA 483 - Pharma Nobis LLC - July 25, 2025

Pharma Nobis LLC in Texarkana, TX, a drug manufacturer, received a Form 483 with two observations. The inspection revealed deficiencies in the quality unit's annual product review process for drug compounding excipients and issues with laboratory data integrity, specifically the enabled raw data deletion function on GC instruments used for product release testing. These findings indicate significant concerns regarding quality control and record-keeping practices.