Lico Industries, LLC., d.b.a. American Towelette Company

This warning letter advises you of significant violations during a U.S. Food and Drug Administration (FDA) inspection of your facility. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.

Violations were observed and documented during an inspection of your drug manufacturing facility, Lico Industries, LLC., d.b.a. American Towelette Company, FDA Establishment Identifier (FEI) 3003411169, at 10390 S. Bermuda Ct., Mohave Valley, AZ, from February 17 to 19, 2026. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor-quality drugs.

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).

We reviewed your March 10, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

The following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility.

Your quality unit (QU) failed to establish and exercise its authority to adequately oversee the manufacture, packing, holding, review, and release of your (b)(4) over-the-counter (OTC) drug products, such as (b)(4). Your firm’s inadequate quality oversight resulted in significant deficiencies in documentation practices, batch record review, investigations, and quality system controls to ensure compliance with CGMP requirements. For example, your QU failed to ensure:

Investigation of any unexplained discrepancy or failure of a batch or any of its components to meet any specifications (21 CFR 211.192).

Establishment of suitable quality oversight procedures (e.g., raw material handling, review of production records, and recalls) (21 CFR 211.22(a)).

Batch production and control records that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188(b)).

Establishment of written procedures describing the handling of all written and oral complaints regarding a drug product (21 CFR 211.198(a)).

In your response, you commit to procedural changes related to batch records, such as discontinuing the use of correction fluid (white-out) and improved temperature monitoring practices.

However, your response is inadequate because it does not adequately acknowledge or address the QU’s failure to exercise its responsibility and authority to ensure the accuracy, integrity, review, and approval of CGMP records. Specifically, your response fails to address significant data integrity lapses documented at your facility which include backdating of quality release labels, entry of temperature data when the thermometer was inoperable, and lack of batch records to document manufacturing activities for drug products.

Your firm’s quality systems are inadequate. For help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR parts 210 and 211, see FDA’s guidance documents:

Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download

Q9(R1) Quality Risk Management at https://www.fda.gov/media/167721/download

ICH Q10 Pharmaceutical Quality System at https://www.fda.gov/media/71553/download

In response to this letter provide:

A comprehensive assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed corrective action and preventive action (CAPA) plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, and contemporaneous records throughout your operation.

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 comprehensive assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification (OOS) results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.

2. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

Your firm failed to adequately clean and maintain non-dedicated drug manufacturing equipment used to fill OTC drug products. For example, our investigator observed stagnant (b)(4) product residue inside the tubing on the filling line with residue accumulating in crevices and on surfaces that come into direct contact with the drug product.

In your response, you state that you developed a comprehensive cleaning procedure and implemented a cleaning validation program. However, your response is inadequate because you fail to address the impact of your inadequate cleaning practices on drug products that remain in distribution. In addition, your response does not address how you will document cleaning in your batch record.

It is your responsibility to ensure that you use only appropriately designed and maintained equipment in the manufacture of your drug products.

In response to this letter, provide:

A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices and encompass each piece of manufacturing equipment used to manufacture more than one product.

A CAPA plan, based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices and timelines for completion. Include the following as part of the assessment and CAPA plan:o a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning.o a list of improvements with an explanation how each will enhance cleaning effectiveness.o improved ongoing verification of proper cleaning execution for all products and equipment.o any other needed remediations.

Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should incorporate oversight from a qualified independent consultant and 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.

Additionally, we observed deficient microbiological testing specifications and test methods for your finished non-sterile OTC (b)(4) drug products. We noted that you limited microbiological testing to aerobic plate counts only and used a method intended for non-pharmaceutical use.

Test methods must be validated to show that they are suitable for their intended use and are equivalent to or better than applicable USP compendial methods. The reproducibility of your test methods is essential to determine if your drug products meet established specifications.

Your quality system does not adequately ensure the 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 (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers) for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.

We strongly recommend that you retain a qualified consultant to assist in your remediation.

In response to this letter, provide:

A comprehensive investigation into the extent of the inaccuracies and inconsistencies in data, records, and reporting including results of the data review for drugs distributed in the United States. Include a detailed description of the scope and root causes of all data integrity deviations.

A retrospective risk assessment of the potential effects of each observed deviation on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by each occurrence of a data integrity event. The assessment should also determine risks posed by current operational conditions, and any needed interim measures.

A management strategy for your firm that includes the details of your global corrective action and preventive action plan to implement attributable, legible, complete, original, accurate, and contemporaneous records throughout your operation. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data, including microbiological and analytical data, manufacturing records, and all data submitted to FDA.

As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.

Unresolved violations may 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.

Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within 15 business days of receipt of this letter. Identify your written response with FEI 3003411169 and ATTN: Niketa Patel.

If you have information that you believe demonstrates that your drug products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.

FDA posts warning letters on www.FDA.gov.