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

The FDA issued a warning letter to Pro Numb Tattoo Numbing Spray, LLC following an inspection from November 5 to 6, 2025, at its Palm Bay, Florida facility. The agency identified significant violations of Current Good Manufacturing Practice (CGMP) and the Federal Food, Drug, and Cosmetic Act, rendering the company’s drug products adulterated and misbranded. Major violations include a failure to perform required laboratory testing on finished products to verify identity and strength before distribution. The company also failed to test incoming raw materials and lacked a valid stability program to support product expiration dates; notably, investigators found records for microbial testing that was never actually performed. Furthermore, the firm did not validate its manufacturing processes or maintain an adequate Quality Unit to oversee production and training. The FDA classified several products, including Pro Numb Tattoo Numbing Spray and TKTX Deep Numbs, as unapproved new drugs because they contain ingredient concentrations and combinations—such as high-level lidocaine and epinephrine—not permitted under the applicable over-the-counter (OTC) monographs. These products were also flagged for making unauthorized medical claims regarding tattooing and piercing. Required actions include hiring a qualified third-party consultant to conduct a comprehensive six-system audit of operations. The company must provide a detailed remediation plan within 15 working days, addressing laboratory practices, data integrity, and process controls. While the firm has committed to a voluntary recall of distributed products, the FDA warned that failure to fully correct these deficiencies could result in legal action, such as product seizures or injunctions.