Specialty Health Products CO, LLC

WARNING LETTER Specialty Health Products CO, LLC MARCS-CMS 726564 — July 07, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name John C. Kavanagh Recipient Title QA/RA Manager Specialty Health Products CO, LLC 2514 E Mohawk Ln, Suite 111 Phoenix , AZ 85050 United States (b)(6), (b)(7)(C) Issuing Office: Center for Devices and Radiological Health United States WARNING LETTER CMS # 726564 July 7, 2026 Dear Mr. Kavanagh: During an inspection of your firm located in Phoenix, AZ, from December 1, 2025, through December 11, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures and markets the Hydro-San Colonic Irrigation System (also known as Hydro-San Plus, Hydro-San, and Hydro-San Plus A Base Unit), the Aqua Cleanse Colonic Irrigation System, and Speculum Kits. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. Quality System Regulation Violation(s) Our inspection revealed that the Hydro-San Plus, Aqua Cleanse, and Speculum Kits are adulterated under section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation found at 21 CFR Part 820. We received your firm’s responses dated January 5, 2026, February 6, 2026, March 5, 2026, April 10, 2026, May 6, 2026, and June 10, 2026. These responses are not adequate for the reasons described below. 1. Failure to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). Specifically, your firm has not conducted design validation for your biocompatibility or shelf life requirements of the Class II colonic irrigation devices (Hydro-San Plus and Aqua Cleanse). a. Your firm does not have evidence that biocompatibility testing per ISO 10993 standards was conducted for the (b)(4) material used in patient-contacting speculums despite your specifications requiring compliance to ISO 10993: Biological Evaluation of Medical Devices. Your QA/RA Manager stated that no such records exist. b. Your firm does not have shelf-life validation studies or accelerated aging data to support the claimed 7-year shelf life for the Hydro-San Plus, despite your own risk analysis document explicitly acknowledging a 7-year shelf life due to possible deterioration of components. c. Your firm’s risk analysis documents are inadequate and do not address risk associated with biocompatibility of your (b)(4) material. Your risk analysis documents do not reference the specific material ( (b)(4) ), specific test reports or laboratory names, or ISO 10993 biocompatibility testing standards. Your firm’s risk analysis for the Hydro-San Plus does not evaluate risks from oxygen administration or materials incompatible with high-oxygen environments. The only documentation provided for the oxygen hose does not indicate that the tubing is rated, tested, or approved for medical oxygen delivery applications. Your firm’s risk analysis identified disinfection as a control measure but failed to ensure the control measure was adequately established. The Hydro-San Plus User Guide specifies only 15 seconds of contact time for the Cetylcide disinfectant, which is non-compliant with the manufacturer’s required 1-minute contact time for sanitizing and 10-minute contact time for virucidal activity. Your firm’s responses are not adequate. Your firm’s CAPA-009 response proposes reviewing the (b)(4) Safety Data Sheet (SDS) and conducting a single cytotoxicity test. An SDS is not a substitute for biocompatibility testing per ISO 10993 standards, and a single cytotoxicity test does not constitute adequate biocompatibility assessment for a device that contacts mucous membranes. Regarding shelf life, your firm produced a report concluding the device does not have a shelf life, which directly contradicts your own risk analysis document that stated a 7-year shelf life. Your firm has not adequately explained this discrepancy or provided evidence that components do not degrade over time. Your firm’s progress reports contain no mention of risk analysis, design validation, biocompatibility testing, or shelf-life studies. 2. Failure to establish and maintain design change procedures as required by 21 CFR 820.30(i). Specifically, your firm’s Design Controls procedure (Rev B, dated 7/14/2023) requires design changes to be documented in Engineering Change Orders (ECOs). However, your firm could not provide ECOs or design change input approval for multiple changes to the Hydro-San Plus device, including: (b)(4) changes ( (b)(4) different valves used in various device models at unknown times with no ECO documentation); and addition of a (b)(4) (implemented at an unknown point in time with no ECO or approval documentation), despite the fact that the work instruction for the Hydro-San Plus Light Unit, Document 020-0003, Rev A, dated 2/5/2024) demonstrates that the (b)(4) strip (part (b)(4) ) is a component of the Model A design. Your firm’s responses are not adequate. Your firm’s CAPA-010 response reveals a gap in understanding what constitutes a design change requiring formal control. The planned assessment of the UV light was scheduled for completion by February 27, 2026, but documentation of the assessment has not been provided. Your firm’s progress reports make no specific reference to establishing or improving design change control procedures, and your firm has not explained how it will identify all previously undocumented design changes, retrospectively review, verify, validate as appropriate, and approve those changes, or prevent future unauthorized design modifications. 3. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). Specifically, a. Your firm’s Aqua Cleanse Work Instruction, which documents your assembly instructions for the Aqua Cleanse device, contains no testing procedures, parameters, or acceptance criteria, and no mention of (b)(4) testing procedures or duration, (b)(4) testing steps or acceptable ranges, or (b)(4) testing protocols. b. Your firm’s disinfection procedures, for the use of Cetylcide disinfectant for disinfecting colonic irrigation devices returned from the field, do not incorporate manufacturer requirements. Your firm’s disinfection procedure, Rev B, dated 6/5/2024 states only “Apply the Cetylcide disinfectant as instructed by the manufacturer” without incorporating specific steps for contact time requirements, dilution ratios, application methods, or verification of disinfection effectiveness. Your firm’s responses are not adequate. Your firm’s CAPA-017 response does not address whether current process parameters are adequate to ensure device safety and effectiveness in that in-process testing instructions are incomplete (missing test durations, steps, and parameters). Your firm’s corrective action regarding contamination control — installing a barrier around the sink while disinfecting field service returns — does not constitute proper contamination control for potentially biohazardous materials, and your firm has not addressed air handling, surface disinfection protocols, or personal protective equipment requirements. Your firm’s progress reports state only that it has “enhanced our processes and practices from receiving to customer service,” which provides no specific information about how process control procedures have been corrected. 4. Failure to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, a. Your firm did not document formal evaluation, review, or investigation of eight complaints. RGA #411 (dated 8/25/2025), which involved a mislabeled speculum shipment, was closed on the same day it was opened without reference to any investigation or evaluation documentation, and no cause analysis was documented. b. Your firm was not consistently documenting all complaints in the RGA Log or on RGA Forms as required by your “ Complaint Handling, Rev. B, 6/11/2024 ”. A Corrective Action Record (CAR #005, dated 1/27/2025) references three customer complaints from January 2025 (customers DM, AD, and SE), but no corresponding RGA numbers or RGA forms exist for these complaints. Your firm’s responses are not adequate. Your firm’s CAPA-008 proposes updating the complaint log and establishing formal complaint meetings but fails to address the fundamental breakdown in complaint investigation methodology. Your firm’s corrective actions focus primarily on documentation updates and form creation but do not establish clear criteria for determining when formal investigations are required, what constitutes an adequate investigation, or how to ensure complaints are properly evaluated for reportability under Medical Device Reporting (MDR) requirements. Your firm’s April 2026 progress report states only that it “started to hold formal CAPA and complaints review meetings,” but provides no evidence that the missing Complaint Report Log has been created, or that a system has been implemented to ensure complaints receive proper evaluation and investigation. 5. Failure to establish and maintain procedures to control all documents that are required by this part, as required by 21 CFR 820.40. Specifically, a. Your firm’s current Servicing procedure (Rev B, dated 6/5/2024) contains no servicing steps or requirements. Instead, the body of the Environmental Controls procedure was inadvertently saved under the Servicing procedure title, and this error was not detected before the procedure was released as a controlled document. b. Multiple controlled documents, including the Device Master Record for the Hydro-San Plus and the Aqua Cleanse Work Instruction, were provided as editable MS Word files without password protection, electronic signatures, or any controls preventing unauthorized modification. The Aqua Cleanse work instruction was also undated and unsigned. Your firm’s responses are not adequate. Your firm’s CAPA-020 addresses individual instances of document control failures but does not demonstrate understanding of the systemic breakdown in your firm’s document control system. Your firm has not explained how the body of one procedure was saved under the title of another and has not addressed the need for a comprehensive overhaul of its electronic document management system, including access controls, audit trails, and version control. Your firm’s progress reports make no mention of document control improvements. Unapproved Device Violation(s) FDA has reviewed the Specialty Health Products website, user’s guide, product catalog, and written orders, and determined that the Hydro-San Plus is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The Hydro-San Plus is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii). Specifically, the Hydro-San Colonic Irrigation System was cleared under K891585 with the following indications: The Hydro-San Colonic irrigation system is to be used when colonic irrigation is indicated. However, your firm’s promotion of the device provides evidence that the device is distributed with an intended use for colon hydrotherapy, which is an alternative practice that flushes the large intestine with warm, filtered water to remove waste typically marketed for general wellbeing, including to boost energy and detoxify the body, rather than for medical indications. This would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval. Examples include: Product catalog for the Hydro-San Plus indicates the firm Specialty Health Products is a leading manufacturer of professional colon hydro-therapy systems. Product webpage states the mission is to “be the premier service provider of professional Colon Hydrotherapy devices and integrated serves [sic].” Product webpage asserts several benefits of professional colon hydrotherapy, including improved digesting health, alleviating constipation and promoting bowel movements, lower risk of cancer, and boosting the body’s retention of vitamins and nutrients. Written orders indicate that the device was approved for sale for colon hydrotherapy to wellness centers. Colonic irrigation systems are classified as Class II if the intended use is “for colon cleansing when medically indicated, such as before radiological or endoscopic examinations” per 21 CFR 876.5220(b)(1). However, per 21 CFR 876.5220(b) (2), a colonic irrigation system is classified as Class III “when the device is intended for other uses, including colon cleansing routinely for general well-being.” Additionally, since the Hydro-San Colonic Irrigation System was cleared under K891585, substantial technological changes were made that significantly affect the safety and effectiveness of the device. Examples include: The Hydro-San Plus System includes the ultra-filtration collection, which are separate filtration canisters for the hot and cold-water filtration (https://shpllc.net/filtration/). Performance and biocompatibility testing is needed to support the safety and efficacy of the filters with the system. The Hydro-San Plus System includes an optional Ultraviolet (UV) Light Unit. Additional performance and electrical safety testing is needed to support the safety and effectiveness of the UV Light Unit. The distribution of colonic irrigation systems with these major changes and without the required premarket authorization may raise serious public health concerns, as colonic irrigation can lead to perforation of the rectum and/or colon, infection, imbalance of electrolytes, dehydration, and microbial dysbiosis. For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency, per 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed Our office requests that Specialty Health Products cease any activities that result in the misbranding or adulteration of the Hydro-San Plus, such as the commercial distribution of the device for the uses discussed above. Unique Device Identifier (UDI)/GUDID Violation The device cleared with K891585, Hydro-San Colonic Irrigation System, is misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, respecting the device. In particular, 21 CFR 801.20(a) requires, with exceptions not relevant here, that the label and device package of every medical device bear a unique device identifier (UDI) that meets the requirements of 21 CFR Part 801, subpart B, and 21 CFR Part 830. Also, 21 CFR 830.300(a) and 830.320(b), both of which were promulgated under section 519 of the Act, among other provisions, require, with exceptions not relevant here, that the labeler of a device submit electronically to FDA’s Global Unique Device Identification Database (GUDID) the information required by 21 CFR Part 830, subpart E, for each version or model required to bear a UDI. FDA has determined that your firm causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. Specialty Health Products is therefore a “labeler” within the meaning of 21 CFR 830.3 and has not submitted to GUDID information required by 21 CFR Part 830, subpart E, respecting this device. The failure or refusal to furnish any notification or other material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, also constitutes a prohibited act under section 301(q)(1)(B) of the Act, 21 U.S.C. § 331(q)(1)(B). Based on a review of the GUDID on June 30, 2026, there are no entries for Hydro-San Colonic Irrigation System under “Specialty Health Products Inc.” or under “Quality Medical Supply.” Your firm’s responses dated January 5, 2026, February 6, 2026, March 5, 2026, April 10, 2026, May 6, 2026, and June 10, 2026, are not adequate. Your firm’s responses do not address GUDID reporting. Registration and Listing Violation During an inspection of your firm, located in Phoenix, AZ, on December 01, 2025, through December 11, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures (or markets) the Hydro-San Colonic Irrigation System (also known as Hydro-San Plus, Hydro-San, and Hydro-San Plus A Base Unit) and the Aqua Cleanse Colonic Irrigation System. In addition to this, you also develop specifications for packaging and labeling of enema (speculum) kits to be sold with these irrigation devices. Specialty Health Products also imports enema (speculum) kits that are already packaged and labeled to distribute in the U.S. Your firm has registered for Fiscal Year 2026, but you have not identified your establishment as an initial importer. You also have not listed the following devices: The modified Hydro-San Plus, using a new premarket submission number Aqua Cleanse enema (speculum) kits Hydro-San Plus enema (speculum) kits Therefore, the devices are misbranded in that they were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)). If you are not manufacturing and marketing the device cleared under K891585, you must deactivate that listing. Specialty Health Products must submit a new premarket submission for the Hydro-San Plus device. This device and the Hydro-San Plus enema (speculum) kits cannot be listed until the new premarket submission has been authorized. After the authorization, your firm must list the devices using the new premarket submission number. You must also list the Aqua Cleanse enema (speculum) kits using K150381. In addition to updating your listing information, you must also update the registration information. The owner/operator contact person must log in and change the owner/operator contact person and official correspondent’s email address and add initial importer to Specialty Health Products’ registration. Instructions explaining how to list exempt and non-exempt devices, update the owner/operator contact person and official correspondent information and add initial importer can be found on our website at: How to Register and List | FDA Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such device will not be approved until the violations have been addressed. Should FDA determine your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted. On February 2, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. The revised part 820, referred to as the Quality Management System Regulation (QMSR), became effective on February 2, 2026. The recent inspection from December 1, 2025 through December 11, 2025 was conducted pursuant to the QS Regulation, which was in effect at the time of the inspection. However, any corrective actions you propose or implement must be pursuant to the QMSR requirements in effect as of February 2, 2026. For more information on the QMSR please refer to our frequently asked questions webpage: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked. Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response. Your firm’s response should be sent via email to Jeffrey Wooley, Acting Assistant Director, at - CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 726564” when replying. If you have any questions about the contents of this letter, please contact Raymond Brullo at raymond.brullo@fda.hhs.gov Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance. Sincerely, /S/ CAPT Cesar A. Perez, PhD, USPHS Acting Deputy Director Office of Regulatory Programs Office of Product Evaluation and Quality Center for Devices and Radiological Health Content current as of: 09/22/2026 Regulated Product(s) Medical Devices