FDA 483 - Pro Numb Tattoo Numbing Spray LLC - November 06, 2025

Pro Numb Tattoo Numbing Spray LLC, a drug manufacturer in Palm Bay, FL, was cited for numerous significant Current Good Manufacturing Practice (CGMP) deficiencies during an FDA inspection. The firm lacked a quality control unit, had untrained personnel, and failed to establish adequate procedures for material handling, storage, process validation, and record-keeping. Additionally, there was no finished product testing, equipment calibration, or stability testing program to ensure product quality and safety.