Lexia LLC MARCS-CMS 722251 — April 07, 2026

WARNING LETTER

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• Delivery Method: VIA EMAIL WITH READ RECEIPT
• Product: Drugs ; Over-the-Counter Drugs

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• Recipient: Mrs. Lois F. Elliott; Co-Owner; Lexia LLC; 367 Riverside Drive, Suite 100; Franklin, TN 37064-8977; United States

• Issuing Office: Center for Drug Evaluation and Research (CDER); United States

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Warning Letter 320-26-59

April 7, 2026

Dear Mrs. Elliott:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Lexia LLC, FEI 3011863647, at 367 Riverside Drive, Suite 1003, Franklin, TN, from September 23 to 29, 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).

We have not received a response from your firm stating the actions you are taking to address the deficiencies identified during the inspection and cited on our Form FDA 483. During the inspection, your firm notified the Agency that you do not intend to manufacture drug products and have discontinued your FDA drug registration. We received your correspondence dated November 26, 2025, accepting the observations made during the inspection and reiterating your decision to discontinue production of drug products.

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. Your firm also failed to conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).

Your firm failed to conduct adequate finished product release testing for each batch of your drug products including, but not limited to, testing the identity and strength of the active ingredient, (b)(4), and testing for objectionable microorganisms.

For example, your firm manufactures (b)(4), an over-the-counter (OTC) topical pain relief drug product. The only tests you perform on the finished product are for viscosity, pH, and color. Your firm stated your OTC drug product lacks a final product specification and does not follow recognized standards.

Appropriate testing is an essential part of ensuring that the drug products you manufacture conform to CGMP. Without adequate finished product release testing, you do not have scientific evidence that each batch of drug product conforms to predetermined specifications before release. In response to this letter, provide:

• A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot 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.
• A comprehensive 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.

2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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 failed to test incoming components used in manufacturing your finished OTC drug products to determine identity, purity, strength, and quality. Additionally, your firm did not establish a vendor qualification program for your raw material suppliers.

Your firm used results from your suppliers’ certificates of analysis (COAs) without establishing the reliability of your suppliers’ analyses through appropriate validation and without conducting at least one specific identity test on each incoming lot of components. You cannot rely on your suppliers’ COAs to verify the identity of your components.

In addition, your firm uses (b)(4) as a component in the manufacture of your OTC topical pain relief drug product. During the inspection, you stated that you do not test your (b)(4) system for objectionable microorganisms, total organic carbon, conductivity, or pH. Your firm has not demonstrated that the (b)(4) is suitable for its intended use for pharmaceutical manufacturing and meets the (b)(4) USP monograph for chemical and microbiological attributes.

The lack of data regarding the state of control of your (b)(4) system poses a potential risk for objectionable microbiological contamination into your drug products. (b)(4) must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. All components, including (b)(4), must be tested prior to use as required by 21 CFR 211.84(a).

(b)(4)

Your firm’s OTC topical pain relief drug product uses (b)(4)

Without adequate testing and confirmation of reliability of supplier and external laboratory testing results, you lack scientific evidence that your components or drug products conform to appropriate specifications.

In response to this letter, please 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 CAPA to remediate the vendor 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 supplier’s 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 commitment to provide (b)(4) test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of (b)(4).

3. Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).

Your firm assigned a (b)(4) expiry period to your OTC topical pain relief product without scientific rationale to support the labeled expiry. At the time of inspection, you lacked stability data to support the (b)(4) expiry period. There was no assurance that your drug product will remain acceptable throughout its labeled expiry period without an established stability program. During the inspection, you stated that your product’s expiry is “anecdotal.”

For products without appropriate stability studies, there is insufficient scientific evidence to support that the drug products will meet established specifications and retain their quality attributes through their assigned expiry.

In response to this letter, provide:

• A comprehensive 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.

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)).

You lacked process validation data to demonstrate that the manufacturing process used to manufacture your OTC topical pain relief product is reproducible and controlled to consistently yield drugs of uniform character and quality.

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

In response to this letter, provide:

• A remediation plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drug products. Provide a more data-driven and scientifically sound program that identifies sources of process variability and assures that manufacturing (including both production and packaging) operations meet appropriate parameters and quality standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, ensuring quality of input materials, determining the capability and reliability of each manufacturing process step and its controls, and vigilant ongoing monitoring of process performance and product quality.

5. Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d).

You lacked a quality unit (QU) with appropriate oversight for the manufacture of your drug products, and you did not have written quality procedures. Your firm has one SOP that does not adequately govern quality processes for CGMP. For example, you failed to ensure the following:

• Investigation of any unexplained discrepancy or failure of a batch or any of its components to meet any specifications (21 CFR 211.192).
• Written records describing the evaluation of quality standards of each drug product at least annually to determine the need for changes in drug product specifications, manufacturing, or control procedures (21 CFR 211.180(e)).
• Failure to retain and store, under conditions consistent with product labeling, an appropriately identified reserve sample that is representative of each batch of drug product (21 CFR 211.170(b).
• Establishment of written procedures describing the handling of all written and oral complaints regarding a drug product (21 CFR 211.198(a)).
• Establishment of a system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary (21 CFR 211.150(b)).
• Establishment of adequate batch production and control records that contain 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 an appropriate program for cleaning and maintenance of equipment (21 CFR 211.67(b)).
• Operators received adequate CGMP training for the production of OTC drug products (21 CFR 211.25(a)).

Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help in 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/71023/download.

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

Drug Production Ceased

We acknowledge your commitment to cease production of all OTC drugs at this facility and that you deregistered your facility as a drug manufacturer.

If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all corrective action and preventive action (CAPA).

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 assist your firm in meeting CGMP requirements. 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.

Cosmetics Manufactured for Distribution in the United States

In addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.

We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.

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 3011863647 and ATTN: Maria Pavco.

Sincerely,
/S/

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