Spa De Soleil, Inc. MARCS-CMS 728508 — July 08, 2026

WARNING LETTER

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• Delivery Method: VIA UPS
• Reference #: 320-26-100
• Product: Drugs ; Over-the-Counter Drugs

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• Recipient: Ms. Rena Revivo; Owner ; Spa De Soleil, Inc.; 10443 Arminta Street; Sun Valley, CA 91352-4109; United States

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

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Warning Letter 320-26-100

July 8, 2026

Dear Ms. Revivo:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Spa De Soleil, Inc., FEI 3003876848, at 10443 Arminta Street, Sun Valley, from January 20 to 26, 2026.

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 February 6, 2026 response to our Form FDA 483 in detail. Your response is inadequate because you failed to provide supporting 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 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 failed to adequately investigate multiple microbiological out-of-limit (OOL) and chemical out-of-specification (OOS) results from testing the water you used to manufacture over-the-counter (OTC) (b)(4) drug products, including (b)(4) and (b)(4). For example, from May 2024 through July 2025, you did not adequately investigate 51 OOL/OOS results from testing your (b)(4). These included results for conductivity and total organic carbon testing that exceeded specifications, as well as the recovery of gram-negative microorganisms from multiple points of use.

Your investigations did not include identification of the recovered microorganisms (e.g., genus, species). You resampled and retested the (b)(4) for microbiological quality to obtain passing results and continued to use the (b)(4). Following an OOL recovery, you also placed certain point-of-use valves on hold until you obtained a passing result. However, this practice did not prevent you from using other valves on the same system. Microbiological recoveries from a (b)(4) system are not uniform, and results obtained at any point in the system can be an indicator of the quality of (b)(4) in the system as a whole. Your identified corrective actions did not adequately prevent the use of (b)(4) with potentially objectionable microbial contamination in the manufacture of your drug products.

Furthermore, your (b)(4) system was not adequately designed or maintained, which could foster the development of biofilms. Specifically, your (b)(4) system included non-sanitary components such as dead legs, threaded fittings, Teflon tape, and ball valves. You also did not demonstrate that you adequately monitored your (b)(4) system to ensure it consistently produced (b)(4) that met appropriate chemical and microbial attributes. For instance, your sampling frequencies were not reflective of batch production schedules.

In your response, you did not provide any supporting documentation, including details of your corrective actions to ensure that future OOS/OOL investigations will be adequate in scope and include root cause determination. You also did not provide a comprehensive review of potentially affected drug products. You state that your historical review of OOS/OOL events from your (b)(4) system determined that no adverse impact to drug product quality or safety was identified.

This retrospective investigation failed to identify adequate corrective action and preventive action (CAPA) plans. You do not commit to changes in monitoring frequency (e.g., reflective of batch production) or identifying and quantifying recovered microorganisms during routine monitoring of your water system. You also fail to consider how fundamental flaws in design, control and maintenance of your (b)(4) system may contribute to the OOS/OOL results. Your CAPA plan is not sufficient to ensure that your (b)(4) system produces (b)(4) suitable for use in OTC drug products.

(b)(4) must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. Routine monitoring of microbial counts and identity of contamination in the system is integral to ensuring oversight of the ongoing state of control and suitability of (b)(4) for use in pharmaceutical manufacturing operations.

In response to this letter, provide:

• A comprehensive review and remediation plan for your OOS and OOL 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 Adequate scoping of each investigation and its CAPA
  o Revised OOS investigation procedures with these and other remediations
  o A similar review and remediation of your system for handling OOL findings (i.e., data that fall outside action limits)
• A comprehensive remediation plan for the design, control, and maintenance of the (b)(4) system.
  o Provide a comprehensive evaluation of vulnerabilities of your (b)(4) system design and control, and summarize all deficiencies found in the system. The summary should, at minimum, describe various system characteristics that were assessed for adequacy (system temperature, materials of construction, slope, any identified dead-legs, any stagnant locations, any unsanitary fittings, flow velocity, etc.)
  o Provide a validation report for the water system obtained after all identified design issues have been fully corrected and any maintenance repairs have been completed. Include the system validation protocol, the complete test results, and the final validation report.
• Your total microbial count limits to monitor whether this system is producing (b)(4) suitable for the intended uses for each of your drug products.
• A detailed risk assessment addressing the potential effects of the observed (b)(4) system failures on the quality of all drug product lots currently in U.S. distribution or within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and drug product recalls.

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)).

You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., (b)(4)) used in the manufacture of your OTC topical drug products. In addition, you relied on your suppliers’ certificates of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.

Products Containing (b)(4)

You failed to adequately test your incoming component (b)(4) at risk of methanol contamination for identity before using it as an active pharmaceutical ingredient (API) in manufacturing your OTC topical drug products. The use of (b)(4) contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4) to help you meet the CGMP requirements when manufacturing drugs containing (b)(4).

Furthermore, you failed to demonstrate that the component (b)(4) you used to manufacture your (b)(4) drug products meets United States Pharmacopeia (USP) monograph specifications or is of adequate quality for its intended use.

Products Containing Ingredients at Risk for Diethylene Glycol or Ethylene Glycol Contamination

You also failed to adequately test your incoming components at high risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing glycerin to determine its appropriate identity prior to use in manufacturing your OTC topical drug products.

Identity testing for glycerin and certain other high-risk drug components includes a limit test in the USP to ensure the component meets the relevant safety limits for DEG or EG levels. 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 assure the acceptability of these components for use in the manufacture of your drug products.

The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.

In your response, you state that your new standard operating procedures require identity and purity testing for all incoming ethanol and identity testing for all incoming OTC materials. You also commit to verifying supplier certificates of analysis prior to raw material release for use in manufacturing your topical OTC drug products. Your response is inadequate because you do not provide sufficient details and supporting data to demonstrate your components meet all compendial requirements. Furthermore, your response does not address testing each shipment of each lot, to include each container, of your high-risk drug components for DEG or EG contamination and ethanol for the presence of methanol contamination.

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

In response to this letter, provide:

• A commitment to provide DEG and EG 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 DEG and EG.
• A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the components and any related drug product that could contain DEG or EG, including customer notifications and drug product recalls for any contaminated lots. Identify additional appropriate CAPA 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.
• 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 COA 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 revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B. and C of the USP monograph.
• The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.
• A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.

3. 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, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).

You failed to ensure adequate validation for each of the manufacturing processes used to produce your OTC drug products. Additionally, your completed batch records did not include details pertaining to critical processing steps subject to variation (e.g., (b)(4) times, speeds) or identification of certain equipment including scales used for your weight-based manufacturing processes.

In your response, you state that you will execute process validation with a target completion date of April 2026. However, your response is inadequate because you provide no assurance of your proposed process validation for each drug product. You did not provide validation plans, and you did not include details pertaining to critical attributes of a (b)(4) process. In addition, you did not consider a retrospective assessment of the potential impact to your drug product distributed in the United States and within expiry.

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.

Also, process qualification studies characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established. They include intensive monitoring and testing throughout each significant process stage.

Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and drug product quality is necessary to ensure you maintain a stable manufacturing operation throughout the drug 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 detailed summary of your validation program for ensuring a state of control throughout the drug product lifecycle, along with associated procedures. Describe your program for process performance qualification and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control. Also, describe your equipment and facility qualification program.
• A timeline for performing appropriate 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 protocols and written procedures for qualification of equipment and facilities.

4. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

You failed to adequately validate your alternative (b)(4) microbiological test methods. Your firm used the (b)(4) system for (b)(4) microbiological testing of your (b)(4), raw materials, and finished drug products (e.g., total counts, objectionable microorganisms). However, you failed to demonstrate that this system was equivalent to or better than USP compendial methods and suitable for its intended use. Specifically, your method validation was fundamentally flawed because you treated a quantitative test as a qualitative limit test, which resulted in unsubstantiated USP <61> equivalency claims.

In your response, you state that you have updated your sampling procedures and now perform growth promotion testing on every lot of (b)(4) microbiological media used by your (b)(4) microbiological testing system. However, your response is inadequate because you do not adequately address how you will ensure that your microbiological limits test method is properly 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 whether your (b)(4), components, and drug products meet established specifications for microbial attributes.

In response to this letter, provide:

• A comprehensive, independent assessment of the design and control of your firm’s manufacturing operations with a detailed and thorough review of all microbiological hazards.
• A detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and drug product recalls.
• Complete investigations into all batches with potential objectionable microbial contamination or an OOS microbiological result (whether or not later invalidated). The investigations should detail your findings regarding the root causes of the contamination.
• Appropriate microbiological batch release specifications (i.e., total counts, identification of bioburden to detect objectionable microbes) for each of your drug products.
• All microbial test methods used to analyze each of your drug products.
• A summary of results from testing retain samples of all drug product batches within expiry. You should test microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each batch. If testing yields an OOS result, indicate the corrective actions you will take, including notifying customers and initiating recalls.

5. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)).

The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. Specifically, your quality unit failed to ensure:

• The adequacy and qualification of contract laboratories used for microbiological testing of raw materials, in-process materials, and finished drug products (21 CFR 211.22(b)).
• Evaluation of the quality standards of each of your (b)(4) drug products at least annually to determine the need for changes in drug product specifications, manufacturing, or control procedures (21 CFR 211.180(e)).
• Proper validation of procedures for cleaning and maintenance of common equipment (21 CFR 211.67(b)).

In your response, you state that you have established a formal contract laboratory qualification program that includes a review of historical data. You also state that you have implemented an annual drug product review written procedure and that you will complete a formal cleaning validation by December 2026. However, your response is inadequate because you provide no supporting documentation to verify your proposed corrective actions. Additionally, your written commitments are similar to those you submitted in response to the FDA inspections conducted in 2021, demonstrating repetitive failures to follow through on implementing your proposed corrective actions.

Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP. In addition to the lack of effective management oversight of your production and laboratory operations, we found that your QU was not enabled to exercise proper authority and insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s manufacturing operations to ensure that your systems, processes, and drug products meet CGMP.

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.

Repeat Violations at Facility

In a previous inspection, dated September 13 to 17, 2021, FDA cited similar CGMP violations. You proposed specific remediations for these violations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.

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 3003876848 and ATTN: Matthew R. Dionne, Pharm.D.

Sincerely,
/S/

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