WARNING LETTER

Pro Numb Tattoo Numbing Spray, LLC MARCS-CMS 722589 — April 14, 2026

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, strength, purity, and microbial testing.

Your response is inadequate. You do not provide sufficient details about the test methods and specifications you implemented for your over-the-counter (OTC) drug products to ensure each batch of your finished products met appropriate standards before release and distribution. Also, you do not commit to performing retrospective testing of your drug product retains (reserve samples) for batches already distributed in the U.S. market.

Drug product batches must be tested for identity, strength, quality, and purity before release. Without sufficient release testing, defective drug products that may pose a risk to consumers are unlikely to be detected.

In response to this letter, provide:

A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
Procedure(s) describing how your firm maintains drug product retains (reserve samples) for each batch manufactured at your facility.
A list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision.
o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.
o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.
The firm name, address, and supplier qualification report for the third-party laboratory or laboratories conducting your drug product release testing.

2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Your firm manufactures OTC topical analgesic drug products without adequate assurance of the quality of raw materials. For example, you did not test incoming components, such as your active pharmaceutical ingredients, for identity before using them in the manufacture of your drug products. Additionally, you relied on your suppliers’ COAs without establishing the reliability of each of your suppliers’ analyses at appropriate intervals.

Without adequate testing, you do not have scientific evidence that your raw materials, including but not limited to active pharmaceutical ingredients, conform to the appropriate specifications before their use in the manufacture of your drug products. As a manufacturer, you are responsible for sampling, testing, and examining drug components before their use in production to ensure adequate quality.

Your firm also used (b)(4) from an external source as a component in your finished drug products without conducting adequate testing to ensure it consistently meets the (b)(4), United States Pharmacopeia (USP) monograph specifications and appropriate microbial limits.

Because (b)(4) is used as a component in your nonsterile drug products, the lack of data regarding the quality of your incoming (b)(4) poses a potential risk of introducing objectionable microbial contamination into your products. (b)(4) purposes must be suitable for its intended use and tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.

In your response, you state you created SOPs for raw material receipt, quarantine, sampling, testing, handling, and approval. You also state you implemented raw material testing at a third-party laboratory and implemented testing for your (b)(4), including testing for (b)(4).

Your response is inadequate. You do not provide raw material specifications, test results, and copies of your SOPs for testing raw materials, including (b)(4). You also fail to provide sufficient details demonstrating how you qualified the contract laboratory used for testing raw materials. In addition, your response does not state if you plan to perform retrospective testing for all lots of components already used to manufacture your drug products, and if you plan to establish the reliability of each of your suppliers’ analyses.

In response to this letter, provide:

A comprehensive, independent review of your material system, including but not limited to:
o evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualified;
o an assessment of all materials to determine whether they are consistently of acceptable quality;
o a review to ensure assigned expiration or retest dates are appropriate (supported by data);
o adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions.
Based on a thorough review, provide a summary of your systems corrective action and preventive action (CAPA) to remediate the supplier qualification program and prevent use of unsuitable components, containers and closures.
The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.
A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your suppliers’ COAs instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.
A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.
A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.
A procedure for your water testing, including sampling, that also specifies routine microbial testing of (b)(4) to ensure its acceptability for use in each batch of drug products produced by your firm.
The firm name, address, and supplier qualification report, for your third-party laboratory or laboratories conducting your raw material testing.

3. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

You failed to demonstrate the quality attributes of your drug products remain acceptable throughout the labeled expiration period. For example, during the inspection, you indicated to the investigator you recorded microbial results on the stability-study data sheet without performing the testing and without any supporting data. You also did not record assay results on your stability-study data sheets for multiple stability time points.

In your response, you explain you have established a compliant stability program, which includes establishing stability SOPs and protocols, implementing accelerated and long-term stability conditions, and submitting initial stability samples to an accredited laboratory. You also state you removed the unsupported (b)(4) expiration date while you determine whether the shelf-life is supported by data.

Your response is inadequate. You do not describe in detail your stability plan with defined stability conditions, time points, and testing of the appropriate critical quality attributes for drug stability, including but not limited to microbiological and impurity testing. Also, you do not specify the expiration date that you are currently using for your finished products after you removed the (b)(4) expiration date.

Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.

In response to this letter, provide:

A comprehensive, independent investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.
A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.
A management strategy for your firm that includes the details of your global CAPA plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.
A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:
o Stability indicating methods
o Stability studies for each drug product in its marketed container-closure system before distribution is permitted
o an ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid
o detailed definition of the specific attributes to be tested at each station (timepoint)
o all procedures that describe these and other elements of your remediated stability program.
The current expiry date for your finished drug products.
The firm name, address, and supplier qualification report for the third-party laboratory or laboratories conducting your drug product stability testing.

4. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Your firm failed to validate your manufacturing processes for your OTC drug products (for example, Pro Numb Tattoo Numbing Spray 5% Lidocaine and Pro Numb Tattoo Numbing Spray 4% Lidocaine for sensitive skin). When asked to provide validation studies for your manufacturing process, you acknowledged not being familiar with process validation requirements.

In addition, the process design and controls for your production did not demonstrate reproducibility or consistency in your manufacturing process. For example, for a (b)(4) to achieve your target batch size, and then you (b)(4). Also, you explained your filling process is to (b)(4), without established fill volume controls.

Furthermore, you explained you perform viscosity in-process testing of your bulk drug product by looking at it, with a specification of “(b)(4),” and without using a viscometer or any other appropriate laboratory instrumentation for your viscosity determination.

You did not establish scientifically sound and technically precise process parameters and process controls to ensure quality, homogeneity, and content uniformity, including fill volume of your drug products.

Your response is inadequate. You do not commit to providing a detailed plan to validate your manufacturing processes.

You are responsible for designing and controlling your manufacturing processes to ensure that they reproducibly yield drug products meeting predefined process parameters and quality attributes.

Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.

Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.

See FDA’s guidance document, Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation, at https://www.fda.gov/media/71021/download.

In response to this letter, provide:

An assessment of each drug product process to ensure that there is a data-driven and scientifically sound program that identifies and controls all sources of variability, such that your production processes, will consistently meet appropriate specifications and manufacturing standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, sufficiency of detectability in your monitoring and testing systems, quality of input materials, and reliability of each manufacturing process step and control.
A timeline for performing process performance qualification (PPQ) for each of your marketed drug products. Also provide a risk assessment and any follow up actions to be taken for the distributed drug products produced without performing any process validation studies.
Process performance protocol(s), and written procedures for qualification of equipment and facilities.
A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control throughout the product lifecycle. Also, include your program for qualification of your equipment and facility.
A comprehensive, independent assessment of your in-process monitoring and sampling operations, focusing on each upstream process step that can introduce variability. Provide your remediation plan to improve: (1) upstream process controls; (2) in-process detection of variation; and (3) sampling plans.

5. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

Your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacturing of drug products. For example, your QU failed to ensure:

Establishment of adequate batch production and control records, with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).
Adequate training for employees engaged in the manufacture, processing, packing, or holding of drug products (21 CFR 211.25(a)).
Establishment of routine calibration and written records of calibration checks according to a written program designed to ensure proper performance of equipment used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)).
Adequate storage and warehousing of drug products, including but not limited to appropriate monitoring of storage conditions for temperature and humidity (21 CFR 211.142).

In your response, you state you have established an independent QU; revised and approved all SOPs; remediated your batch manufacturing records; created training files, including complete GMP training of all personnel; implemented an equipment calibration program; and installed calibrated temperature and humidity data loggers with defined storage ranges to monitor your storage areas.

Your response is inadequate. You do not provide sufficient information and supporting documentation to verify the adequacy and effectiveness of your corrective actions.

Your firm’s quality systems are inadequate. See FDA’s guidance document ICH Q10 Pharmaceutical Quality System, as well as Quality Systems Approach to Pharmaceutical CGMP Regulations, for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71553/download and https://www.fda.gov/media/71023/download, respectively.

In response to this letter, provide:

A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
o A determination of whether procedures used by your firm are robust and appropriate
o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
o A complete and final review of each batch and its related information before the QU disposition decision
o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.
A complete, independent assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.
Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.
Your QU authority and responsibilities procedure, SOP-QA-001.
Your organizational chart and current number of CGMP employees.
Your procedure for your environmental controls and alarm limits for your storage areas.

Unapproved New Drug and Misbranded Drug Violations

“PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.

Examples from the “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” products’ labeling, including your website, https://tattoonumbingsprays.com/, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:

“PRO NUMB TATTOO NUMBING SPRAY” and “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN”
“Topical Anesthetic to take away pain” [from your product labels]

“Takes away Pain, Swelling, and Redness during tattoo procedures” [from your product labels]

“Temporarily takes away pain, itching, and swelling associated with anorectal disorders or pain-sensitive procedures” [from your product labels]

“Instantly removes pain…” [from your product website]

“Tattoo Pain Relief” [from your product website]

“PRO NUMB TATTOO NUMBING SPRAY”
“5% lidocaine temporarily blocks pain signals in the brain” [from your product website]

“PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN”
“4% lidocaine temporarily blocks pain signals in the brain” [from your product website]

“TKTX Deep Numbs”
“Usable Range Micro Needle Pain Tattooing Body Piercing, Laser Tattoo Removal, Laser Hair Removal, Waxing, Permanent Cosmetics” [from the product label]

Unapproved New Drug Violations

Based on the above labeling evidence, “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” are intended for use as external analgesic drug products, among other intended uses.¹ As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for the drug products identified above.

Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. With respect to nonprescription external analgesic drug products, such as your “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs,” in order to be GRASE and not new drugs, the products must, among other things, conform to the conditions in the applicable OTC monograph, Over-the-Counter Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use (“M017”).² However, “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” do not conform to the conditions specified in M017 for the reasons described below.

The labeled concentrations and/or combinations of active ingredients identified in the product labeling for “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” do not conform to the conditions of use set forth in M017. Specifically, lidocaine, an active ingredient labeled to be in all three products, is listed as lidocaine 5% in “TKTX Deep Numbs” and lidocaine hydrochloride 5% in “PRO NUMB TATTOO NUMBING SPRAY.” This concentration is above the 0.5% to 4% concentration range of lidocaine and lidocaine hydrochloride permitted under M017.10(a).

As formulated, both “PRO NUMB TATTOO NUMBING SPRAY” and “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN” contain a combination of the active ingredients lidocaine and epinephrine, and “TKTX Deep Numbs” contains a combination of the active ingredients lidocaine, epinephrine, and prilocaine. None of these combinations of active ingredients in a single external analgesic drug product are permitted under M017.20. Furthermore, epinephrine, epinephrine HCl, and prilocaine are not permitted ingredients under M017, and prilocaine is not a permitted active ingredient in any final administrative order issued in accordance with section 505G.

Additionally, the labeling for “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” includes indications that are not permitted for external analgesic drug products under M017.50(b). Indications related to tattooing, piercing, and/or minor cosmetic procedures are not permitted under M017 or in any other final administrative order in accordance with section 505G.

Thus, “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” products do not comply with the applicable conditions specified in M017 and have not otherwise been found GRASE.³ Accordingly, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which these products would be legally marketed without an approved application. Because there are no applications in effect for these products, these products are unapproved new drugs.

The introduction or delivery for introduction of these unapproved new drugs into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

Misbranded Drug Violations

Additionally, “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of any applications approved under section 505 of the FD&C Act, 21 U.S.C. 355. The introduction or delivery for introduction of misbranded drugs into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Drug Recall

On January 28, 2026, FDA held a teleconference with you recommending you consider removing any batches of Pro Numb Tattoo Numbing Spray and Pro Numb Tattoo Numbing Spray for Sensitive Skin currently in distribution from the U.S. market.

You communicated your commitment to voluntary recall all batches of your Pro Numb Tattoo Numbing Spray drug products within expiry.

CGMP Consultant Recommended

Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit⁴ of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.

Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3027228716 and ATTN: Sai Dharmaraj.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

/S/

Tina Smith
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research

_______________________

1 We note that “PRO NUMB TATTOO NUMBING SPRAY” and “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN” also appear to be indicated to relieve pain associated with anorectal disorders. OTC anorectal drug products are deemed to be GRASE and not new drugs if, among other things, they conform to the conditions of use set forth in the final administrative order, Over-the-Counter Monograph M015: Anorectal Drug Products for Over-the-Counter Human Use (“M015”). (See Order ID OTC000009, available at FDA’s website OTC Monographs@FDA). These products also do not conform to the conditions set forth in this monograph.

2 M017 reflects the conditions set forth in the relevant final order established and in effect under section 505G; see Order ID OTC000033, available at FDA’s website OTC Monographs@FDA https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm.

3 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “PRO NUMB TATTOO NUMBING SPRAY,” “PRO NUMB TATTOO NUMBING SPRAY FOR SENSITIVE SKIN,” and “TKTX Deep Numbs” products are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b).

4 i.e. Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.