Pro Numb Tattoo Numbing Spray, LLC — FDA Warning Letter, 2026-04-14: Nonprescription/OTC
Letter issued · posted to fda.gov .
Subject as published: Nonprescription/OTC
TL;DR
FDA issued a Warning Letter to Pro Numb Tattoo Numbing Spray, LLC on 2026-04-14 citing: Nonprescription/OTC. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pro-numb-tattoo-numbing-spray-llc-722589-04142026
Argus analysis
Pro Numb Tattoo Numbing Spray, LLC (MARCS-CMS 722589, FEI 3027228716) received an FDA Warning Letter dated April 14, 2026 from the Center for Drug Evaluation and Research (CDER). The letter cites: Nonprescription/OTC. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on April 21, 2026.
Nonprescription/OTC letters typically cite the relevant OTC monograph under 21 CFR Part 330 (or the newer OTC monograph order process under the CARES Act) alongside 21 USC 352 misbranding provisions. Common findings involve active ingredients, dosing, or labeling claims that fall outside the applicable monograph's permitted conditions.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same general compliance category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Pro Numb Tattoo Numbing Spray, LLC MARCS-CMS 722589 — April 14, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-26-63 Product: Drugs Recipient: Recipient Name Mr. Justin T. Zahnter Recipient Title Owner Pro Numb Tattoo Numbing Spray, LLC 3778 Dixie Highway NE, Suite C Palm Bay , FL 32905-2727 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-63 April 14, 2026 Dear Mr. Zahnter: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Pro Numb Tattoo Numbing Spray, LLC, FEI 3027228716, at 3778 Dixie Highway NE, Suite C, Palm Bay, from November 5 to 6, 2025. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). In addition, “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” drug products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). Additionally, these drug products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below. CGMP Violations We reviewed your November 13, 2025 response to our Form FDA 483 in detail. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP. During our inspection, our investigator observed specific violations including, but not limited to, the following. 1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)). Your firm failed to adequately test batches of your drug products before release and distribution. You stated your firm does not perform finished product testing. In your response, you state you contracted a third-party laboratory to perform full release testing, and you implemented finished product specifications, Certificates of Analysis (COAs), and a standard operating procedure (SOP) for identity,…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has Pro Numb Tattoo Numbing Spray, LLC had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Pro Numb Tattoo Numbing Spray, LLC as of 2026-04-21. Argus ingests new FDA enforcement records daily.
- What FDA violations was Pro Numb Tattoo Numbing Spray, LLC cited for?
- The FDA Warning Letter to Pro Numb Tattoo Numbing Spray, LLC (issuing office: Center for Drug Evaluation and Research (CDER)) cites: Nonprescription/OTC. Classification: Warning Letter.
- When did FDA issue the warning letter to Pro Numb Tattoo Numbing Spray, LLC?
- FDA issued the letter (MARCS-CMS 722589) on 2026-04-14 and posted it publicly on fda.gov on 2026-04-21.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Pro Numb Tattoo Numbing Spray, LLC — FDA Warning Letter, 2026-04-14: Nonprescription/OTC. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-pro-numb-tattoo-numbing-spray-llc-2026-04-14-warning-letter
"Pro Numb Tattoo Numbing Spray, LLC — FDA Warning Letter, 2026-04-14: Nonprescription/OTC." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-pro-numb-tattoo-numbing-spray-llc-2026-04-14-warning-letter.
Argus HQ Research. "Pro Numb Tattoo Numbing Spray, LLC — FDA Warning Letter, 2026-04-14: Nonprescription/OTC." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-pro-numb-tattoo-numbing-spray-llc-2026-04-14-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_pro_numb_tattoo_numbing_spray_llc_2026_04_14_warning_letter_2026,
title = {Pro Numb Tattoo Numbing Spray, LLC — FDA Warning Letter, 2026-04-14: Nonprescription/OTC},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-pro-numb-tattoo-numbing-spray-llc-2026-04-14-warning-letter},
note = {Accessed: July 13, 2026}
}