FDA 483 - Pro Numb Tattoo Numbing Spray LLC - November 06, 2025
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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.
- Office
- Florida District Office
- Person
ID · 484b182e-9b91-43e0-8830-218d3e727f4a