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WARNING LETTER

Absolutely Natural MARCS-CMS 715690 —

Delivery Method:
Via Electronic Mail - Return Receipt Requested
Reference #:
320-26-35
Product:
Drugs
Over-the-Counter Drugs
Recipient:
Recipient Name
Mr. Daniel Richards
Recipient Title
President
Absolutely Natural

640 Atlantis Road
Melbourne, FL 32904-2315
United States

Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

Warning Letter 320-26-35

December 30, 2025

Dear Mr. Richards:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Absolutely Natural, FEI 3004606446, at 640 Atlantis Road, Melbourne, from April 22 to 24, 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 reviewed your May 15, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

During our inspection, our investigators observed specific violations including, but not limited to, the following.

1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

You manufacture (b)(4) over-the-counter (OTC) non-sterile drug products, including those labeled for use in (b)(4).

You failed to conduct an adequate investigation in July 2024 when a batch of drug product failed microbiological testing due to out-of-specification (OOS) results for both total plate count and Pseudomonas aeruginosa. Although you rejected the batch, you failed to adequately assess the root cause of the microbiological contamination, and you failed to extend the investigation to additional batches that may also have been affected.

It is necessary to conduct a thorough, well documented, and scientifically sound investigation to identify the root cause of an OOS, to evaluate all potentially affected batches, and to implement a timely and effective corrective actions and preventive actions (CAPA) plan.

In your response, you described the following activities that you initiated after the inspection: (1) You performed a risk analysis; (2) you initiated an investigation into the OOS incident noted above; (3) you revised your OOS investigation procedure to include root-cause determination; (4) you retrained personnel on revised procedures; and (5) you conducted a retrospective review of OOS results.

Your response is inadequate because your investigation did not adequately assess additional drug products that may have been affected by this microbiological contamination. Additionally, your response lacks sufficient details about your retrospective review of OOS results.

In response to this letter, provide:

  • A retrospective, independent review of all invalidated OOS (including in-process and release/stability testing) results for U.S. products currently in the U.S. market and within expiry as of the date of this letter and a report summarizing the findings of the analysis, including the following for each OOS:
    o Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrates causative laboratory error.
    o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.
    o For all OOS results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements.
  • A comprehensive review and remediation plan for your OOS result investigation systems. The CAPA should include but not be limited to addressing the following:
    o Quality unit oversight of laboratory investigations
    o Identification of adverse laboratory control trends
    o Resolution of causes of laboratory variation
    o Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified
    o Adequately scoping of each investigation and its CAPA
    o Revised OOS investigation procedures with these and other remediations
  • A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, 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.
  • An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program when needed, implements final quality unit decisions, and is fully supported by executive management.

2. Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).

You failed to adequately validate your alternative rapid microbiological test methods. You use the (b)(4) system for rapid microbiological testing of your finished drug products (for example, total counts, objectionable microorganisms) and failed to demonstrate that it was equivalent to or better than United States Pharmacopeia (USP) compendial methods and suitable for its intended use. For example:

  • Your method did not meet the minimum requirements for quantification and adequate identification of objectionable microorganisms.
    o The microbiological testing methodology employed uses qualitative pass/fail criteria that did not ensure appropriate quantitative enumeration. This approach is insufficient because it does not provide adequate quantitative data regarding contamination levels, which are essential for trend analysis and evidence-based risk assessment to support patient safety determinations. This is highlighted in the OOS investigation referenced in the violation mentioned above.
    o You failed to demonstrate that the (b)(4) system is appropriate for detecting Burkholderia cepacia complex (BCC), a contamination risk in nonsterile (b)(4) drug products.
  • You stated that this system was validated by the manufacturer, but you failed to verify the manufacturer’s validation or perform appropriate validation studies on the instrument installed at your facility.
  • The validation studies you provided deviated from compendial methods by excluding challenge organisms and reducing sample volumes without providing adequate scientific rationale.

In your response, you state that your alternative rapid microbiological test methods are adequately validated. You also state that you performed a risk analysis and “found there is a low risk to the end user.” Your response does not adequately address how you intend to ensure that your method is validated for its intended use.

Test methods must be validated to show that they are suitable for their intended use and 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 for microbial attributes.

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.
  • A comprehensive evaluation of microbiological tests methods used to perform total counts and identification to evaluate suitability for intended use, followed by systemic CAPA, including but not limited to:
    o A comprehensive retrospective evaluation review of each test method to determine any inadequacies, including but not limited to those cited in this letter.
    o Where a method is found unsuitable for its intended use (e.g., inadequate capacity to enumerate), provide information on a new suitable method that will be employed
    o Improved systems to ensure selection and suitability of microbiological test methods in future before implementation.
    o Once this full evaluation is complete, provide all findings, data, and deviations encountered.
  • Following review by an independent third-party, provide updated validation protocols and final reports that adequately address methods for each product, including specificity, limit of detection, robustness, ruggedness, and repeatability. This should include an evaluation of whether sample sizes are appropriate. Where you intend to use non-compendial methods, provide studies evaluating the equivalence or superiority of the method to the USP method.
  • A commitment to establish release and stability specifications for the absence of BCC in drug products, and to implement risk-based sampling and testing procedures to monitor and control potential sources of BCC contamination.
  • Updated analytical procedures, including confirmatory testing and speciation, that ensure regulatory compliance for all microbiological testing. This should also include an explanation of whether sample preparations are reserved to assist in conducting OOS investigations.

3. Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).

You failed to perform adequate identity testing of each incoming component lot, such as (b)(4), used in the manufacture of your OTC drug products.

Identity testing of high-risk drug components such as (b)(4) include limit tests in the USP to ensure that the component meets the relevant safety limits for (b)(4) levels, respectively. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects hazardous impurities, you failed to ensure the acceptability of these components for use in the manufacture of your drug products.

(b)(4)

You failed to adequately test each shipment of each lot of (b)(4), which is used as an inactive ingredient in your drug products, for (b)(4) contamination. Identity testing for (b)(4) and certain other high-risk drug components includes a limit test in the USP to ensure that the component meets the relevant safety limits for levels of (b)(4). Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to ensure the acceptability of this component for use in the manufacture of your drug products.

The use of ingredients contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4).

(b)(4)

You failed to adequately test your incoming (b)(4), which is used as an active pharmaceutical ingredient in your drug products, for (b)(4). The use of (b)(4) contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4).

In your response, you state that you revised your procedures to ensure adequate identity testing of each component lot used in the manufacture of your OTC drug products. You also state that you resampled the (b)(4) currently in your inventory.

Your response is inadequate because it does not consider retrospective identity testing of reserve samples, or assessment by other methods, of the components used in your OTC drug products that were manufactured, distributed, and remain within expiry but were not represented by the (b)(4) currently in your inventory.

Without adequate testing, you do not have scientific evidence that your components conform to the appropriate specifications before use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before use in production to ensure adequate quality.

In response to this letter, provide the following:

  • 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.
    o Based on a thorough review, provide a summary of your systemic 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 each 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’ Certificates of Analysis (COAs) instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your suppliers’ 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 your program for qualifying and overseeing the contract facilities that test the drug products you manufacture.
  • A commitment to provide (b)(4) test results, no later than 30 calendar days from the date of this letter, from testing the 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).
  • A full risk assessment for drug products that are within expiry which contain any ingredient at risk for (b)(4) contamination (including, but not limited to, (b)(4)). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain (b)(4), including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPAs that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.

Quality Systems

Your firm’s quality systems are inadequate. See FDA’s guidance document 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/71023/download.

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 3004606446 and ATTN: CDR Frank Verni.

Sincerely,
/S/

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

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