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WARNING LETTER

Sea-Long Medical Systems, LLC MARCS-CMS 647320 —


Delivery Method:
VIA Electronic Mail
Product:
Medical Devices

Recipient:
Recipient Name
Mrs. Valarie A. Austin
Recipient Title
Chief Executive Officer (CEO) and Co-owner
Sea-Long Medical Systems, LLC

2498 FM 66, Building 1021
Waxahachie, TX 75167
United States

vaustin@sea-long.com
Issuing Office:
Division of Medical Device and Radiological Health Operations West

United States


WARNING LETTER
CMS 647320

April 4, 2023

Dear Mrs. & Mr. Austin,

During an inspection of your firm located at 2498 FM 66, Building 1021, Waxahachie, TX 75167 on 08/22/2022 through 09/08/2022, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of a latex single use neck seal plus small/large hood with/without port (P/N: 5012, 5015, 5002 and 5005), a non-latex single use neck seal plus small/large hood with/without port (P/N: 5035, 5025, 5022 and 5000), a non-latex multi-patient neck seal plus small/large hood with/without port (P/N: 5335, 5325, 5322, and 5300) and a latex multi-patient neck seal plus small/large hood with/without port (P/N: 5312, 5315, 5302 and 5305), hereafter referred to as Sea-Long Medical Treatment Hoods. 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.

Observations Pertaining to Quality System Regulation Provisions and Regulations

This inspection revealed that these devices are adulterated within the meaning of 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from your firm on 09/21/2022 concerning our investigators’ observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).

Specifically, your complaint handling procedures, “Customer Complaint - (MDR) Medical Device Reporting and Recall” (OP-85-01, dated 09/08/2017) and “How to process a Customer Complaint Procedure” do not adequately include requirements to document the nature and details of the complaint and the dates and results for any investigation. Your firm is missing this information in the five (5) complaint records listed below:

  • Customer complaint record dated 12/07/2020 related to “hood with a hole”
  • Customer complaint record dated 03/04/2021 related to “damage hoods”
  • Customer complaint record dated 12/07/2021 related to “hood defect”
  • Customer complaint record dated 07/13/2022 related to “bad weld on hoods and small hole in neck seals”
  • Customer complaint record dated 02/08/2022 related to “neck seals ripped”

Your firm also determined that the devices involved in the complaint records above failed to meet specification and are manufacturing defects, and at least three (3) complaint events involved a device that was used during treatment or analysis. However, all five (5) complaint
records did not contain a “Corrective Action/Preventive Action form” and “Root Cause Analysis form” as required by your complaint handling procedure. Also, there was no rationale why no investigation was necessary and the name of the person(s) responsible for the decision not to investigate in any of the records.

Furthermore, your firm is missing a complaint log as acknowledged by your management and product IDs for all 5 complaint records above as required by your complaint handling procedures. Your firm is missing device serial numbers (complaint record dated 12/07/2021, 07/13/2022, and 02/28/2022) as required by your complaint handling procedures.

The adequacy of your firm’s response cannot be determined at this time. Your response indicated procedural updates were made, but no documentation or evidence was provided.

2. Failure to establish procedures for process validation where the results of a process cannot be fully verified by subsequent inspection and test; failure to validate the process with a high degree of assurance; and failure to approve the process according to established procedures, as required by 21 CFR 820.75(a).

Specifically, your firm did not conduct process validation per your established procedure, “Verification and Validation” (SP-000004, dated 08/22/2022), for the following:

  • The (b)(4) welding process used to manufacture the Treatment Hoods (hyperbaric chambers). Your firm utilizes (b)(4) welding machines (serial numbers: (b)(4), and (b)(4)) for manufacturing of your Treatment Hoods. The (b)(4) welding machines utilize various welding parameters such as seal time, cooling time, and power.
  • The cleaning process used in cleaning of your Treatment Hoods (specifically the hood component) that are reusable on multiple patients. Your firm’s “Sea-Long Product Cleaning Guideline” (with no document number, dated 2020) for your Treatment Hoods (consisting of the hood and neck seal) provides information on the use of EPA registered hospital disinfectants (Sanizide Pro or Plus). The cleaning guidelines provide a contact time of (b)(4) for most EPA-registered hospital disinfectants as well as at least (b)(4) based on multiple scientific studies on hospital disinfectants against pathogens.

The adequacy of your firm’s response cannot be determined at this time. Your response indicated procedural updates were made, but no documentation or evidence was provided.

3. Failure to establish and maintain procedures for design change to ensure the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).

Specifically, as acknowledged by your management, your firm has not established design change procedures for your Treatment Hoods (hyperbaric chambers).

The adequacy of your firm’s response cannot be determined at this time. Your response indicated procedural updates will be made, but no documentation or evidence was provided.

4. Failure to establish and maintain procedures for corrective and preventive action, as required by 21 CFR 820.100(a).

Specifically, your firm failed to establish a procedure for implementing corrective and preventive actions. During the inspection, your management stated that your firm has not established any quality system procedures including CAPA procedures. Also, the “Masterlist of Operating Procedures” (print dated 08/21/2022) directs firm personnel to use the old CAPA procedure (SP-000022, dated 09/02/2005) from the firm’s previous quality management system. Review of the old procedure directs the person to an electronic file; however, the file path was corrupt, and the file was unable to open or unretrievable.

The adequacy of your firm’s response cannot be determined at this time. Your response indicated procedural updates will be made, but no documentation or evidence was provided.

5. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).

Specifically, your firm did not adequately establish your nonconforming procedure, “Non-Conforming Material” (OP-83-00, dated 03/14/2021). For example, your management stated that your firm is utilizing the “Inspection Specification Sheet” (created on 04/08/2004) to document leaks, scratches, and dents during the hood quality checks. The “Inspection Specification Sheet” is not referenced or captured in your nonconforming material procedure. Also, your firm does not store or maintain records of completed Inspection Specification Sheets and was unable to provide the investigator with records from 2021.

The adequacy of your firm’s response cannot be determined at this time. Your response indicated procedural updates will be made, but no documentation or evidence was provided.

6. Failure to establish and maintain procedures for finished device acceptance, to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d).

Specifically, your firm did not have written procedures for finished Treatment Hood device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. During the inspection, your management stated that you had not established any procedure addressing finished device acceptance. Also, during the inspection, your firm created and provided the “Treatment Hood Inspection Process” procedure (OP-85- 02 version 1.0, effective 08/26/2022). This new procedure did not address requirements for completing and retaining your “Inspection Specification Sheet” (no form number and created on 04/08/2004) and “Quality Control (b)(4) Tracking Report” (no form number or date). The “Inspection Specification Sheet” requires recording pass/fail results during hood inspections for criteria such as:

  • Assurance that there are no holes, gaps, or tears/cuts in the hood material
  • Assurance that the weld of the ring is secure and completely sealed
  • Assurance that there are no holes, gaps, or tears/cuts in the hood material
  • Assurance that the (b)(4) is completely sealed around the ports to prevent leaks

The adequacy of your firm’s response cannot be determined at this time. Your response indicated procedural updates will be made, but no documentation or evidence was provided.

7. Failure to establish and maintain procedures for acceptance of incoming product to ensure acceptance or rejection shall be documented, as required by 21 CFR 820.80(b).

Specifically, your firm did not establish your Inspection and Testing procedure (SP-000028, dated 09/19/2017) and “Warehouse Receiving Inspection” (OP-74-03, no date). For example, your firm did not document incoming inspections for at least 12 out of (b)(4) product shipments from supplier of latex neck seals and (b)(4) neck seals that you received between July 2020 to August 2022.

The adequacy of your firm’s response cannot be determined at this time. Your response indicated procedural updates will be made, but no documentation or evidence was provided.

8. Failure to maintain device master records (DMRs), as required by 21 CFR 820.181.

Specifically, your firm did not maintain device master records (DMRs) for the Treatment Hood (hyperbaric chamber), to include or refer to the location of current device specifications (e.g., drawings and component specifications), production and process specifications, quality assurance procedures, and packaging and labeling specifications to ensure that each DMR is prepared and approved in accordance with document controls.

The adequacy of your firm’s response cannot be determined at this time. Your response indicated procedural updates will be made, but no documentation or evidence was provided.

9. Failure to establish and maintain procedures for device history records (DHRs) to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of 21 CFR part 820, as required by 21 CFR 820.184.

Specifically, your firm did not establish a procedure for creating and adequately documenting device history records (DHR) for the Treatment Hoods (hyperbaric chambers). For example, your firm's last documented DHR for the Treatment Hoods using manufacturing procedure router was in 2018 and your Office Manager indicated that your firm has been manufacturing Treatment Hoods (including hood and neck seals) after 2018.

The adequacy of your firm’s response cannot be determined at this time. Your response indicated procedural updates will be made, but no documentation or evidence was provided.

10. Failure to establish procedures for quality audits and to conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.

Specifically, your firm failed to establish your Internal Audits Procedure (OP-82-02, dated 08/22/2022). According to your procedure, “Quality Manager will plan and determine the audit schedule on an ongoing basis.” Your procedure failed to define and document what “ongoing basis” means in the procedure. Also, your firm did not have any documented evidence of audits being conducted or documentation of review of any audit reports since 2018, and your management stated that the firm had not conducted any quality audit since 2016.

The adequacy of your firm’s response cannot be determined at this time. Your response indicated procedural updates will be made, but no documentation or evidence was provided.

11. Failure to establish procedures for management review to ensure that management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency, as required by 21 CFR 820.20(c).

Specifically, your firm failed to establish your “Management Review” procedure (OP-56-01, version 1.2). Your procedure requires management reviews to be conducted at least (b)(4); however, your firm did not have any documented evidence of any annual management review meetings since 2018.

The adequacy of your firm’s response cannot be determined at this time. Your response indicated procedural updates will be made, but no documentation or evidence was provided.

Observations Pertaining to Other Regulations

Your firm currently holds a 510(k) clearance (K010659) for the “Sea-Long Medical Treatment Hood,” which was issued on May 16, 2001. The device was classified under regulation number 21 CFR 868.5470, Hyperbaric chamber, with the following Indications for Use statement: “The Treatment Hood is intended to: provide the use any place that a clinician would normally use a mask for medical purposes of supplying gas/oxygen/air. There is a connector attachment on the hood to allow the Treatment Hood to be connected to a standard gas/oxygen/air supply source.”

However, statements on your firm’s website1 and in materials collected during the inspection indicate that the device is also intended for noninvasive ventilation (NIV), respiratory distress/illness, acute respiratory distress syndrome (ARDS), pressure support ventilation (PSV)/positive end-expiratory pressure (PEEP), COVID-19 treatment, and other additional uses, which constitute major changes or modifications to its intended use for which your firm lacks clearance or approval. Examples include the following:

Your website (https://www.sea-long.com) promotes the following new intended uses:

  • Your “About” page states, “Second Study by pulmonologist John P. Kress, MD showing the helmet ‘confers several advantages over the face mask’. Check out the study here” and includes a link that takes the viewer to an article on The University of Chicago Medicine’s website dated March 25, 2020, and titled, “Helmet-based ventilation is superior to face mask for patients with respiratory distress.” The article indicates that “In a second study published in 2018, the researchers followed up with the same patients after one year. The patients who received helmet ventilation were more likely to be functionally independent than those given a face mask and spent more days living at home. The initial study, published in JAMA, followed 83 patients with ARDS, a severe and often lethal injury to the lungs. ARDS causes fluid to accumulate in the lungs' microscopic air sacs. It can lead to partial collapse of the lungs, dangerously low blood-oxygen levels and death.” [ARDS]
  • Your “Media” page includes excerpts from and links to various media articles and videos, including:

  o An NBC news article and video titled, “Texas ‘mom and pop’ business flooded with orders for helmet-style ventilation device,” dated March 31, 2020. The description under the title states that “Sea-Long Medical Systems has drawn huge interest from hospitals and foreign countries seeking alternatives in treating patients suffering with respiratory illness amid a ventilator shortage during the pandemic.” The link takes you to the NBC news article with video. The description under the title of the NBC news article states that “Sea-Long Medical Systems has drawn huge interest from hospitals and foreign countries seeking alternatives in treating COVID-19 patients amid a ventilator shortage.” The article states that the “helmet was originally designed to supply oxygen to patients receiving treatment in hyperbaric chambers. But doctors in Italy, where a version of the helmet has long been used to treat people experiencing breathing problems, found it to be effective in helping some COVID-19 patients […] Dr. Bhakti Patel, who has been studying the devices for six years, said they hold promise as an early intervention that could spare respiratory patients the need to be put on the more traditional — and costly and invasive — ventilators. […] The original devices were made to run through ventilators. But working with Patel and her mentor, Dr. John Kress, Sea-Long has modified the helmets so they can be hooked up to a hospital’s regular oxygen supply, keeping the ventilators free for those who need them most. They have also made another significant modification, adding a viral filter to prevent possible COVID-19 exposure to others. […] Other companies make similar ventilator helmets, but Sea-Long’s is the only helmet available in the U.S. that meets requirements of the Food and Drug Administration and has been validated in a clinical study for acute respiratory syndrome. No studies have yet been done, however, examining the effectiveness of the devices in treating COVID-19 patients.” [COVID-19 and ARDS]

  o A Fox News article with the description, “Company flooded with orders for helmet ventilators calls for government assistance to ‘scale up’ production,” published April 2, 2020. The article states that “[t]he owner of Sea Long Medical Systems said on Thursday that the flood of ventilator mask orders at his company requires a ‘scaling up’ of production to meet the demand from hospitals fighting the coronavirus outbreak. ‘We’re just completely inundated with phone calls from all over the world from India to anywhere you can think of plus the majority of the hospitals in the United States,’ Chris Austin told ‘America’s Newsroom’. […] Austin said that the masks are used in hospitals at the University of Chicago, University of Pennsylvania, a ‘few’ veterans' hospitals and others.” [COVID-19]

  o A Fox News video titled, “Company demonstrates how helmet ventilation device works amid pandemic,” and a video with a chyron at the bottom of the screen that states, “CHRIS AUSTIN | SEA-LONG MEDICAL SYSTEMS OWNER” and “HELMET VENTILATORS COULD HELP EASE SHORTAGE OF TRADITIONAL VENTILATORS AMID PANDEMIC.” The video shows a snapshot of Sea-Long Medical System’s website stating “COVID - 19 Update: Please contact us for updated information and break thru uses for our products with CPAP, BIPAP and NON-INVASIVE VENTILATION. Check out the information from the Helmet Based Ventilation website-based ventilation is a solution for COVID-19 treatment.” [Ventilator, CPAP, and BIPAP]

  o Your “Media” page has an embedded link to a video from the CBS DFW YouTube channel uploaded March 27, 2020 with the description, “Family-Owned Business Making Medical Devices that Can Ease the Ventilator Shortage: A small family-owned business is making medical devices to help fight the shortage of ventilators during the pandemic.” The video narration introduces a small family own business in Waxahachie and states that “Christopher Austin is the owner of Sea-Long Medical Systems.” The narration states that “once used to supply oxygen to patients receiving treatment in hyperbaric chambers. The device now called the COVID-19 helmet.” [Ventilator and COVID-19]

Your YouTube Channel (https://www.youtube.com/channel/UCQ2YgVWpxMr8gYyMlaWhBA/featured) promotes the following intended uses:

  • “Watch this video to learn how to install a Sea-Long Covid 19 kit. www.sea-long.com.” Also, the YouTube channel directly links (1-click away) to the Sea-Long Medical Systems, LLC’s website. [COVID-19]

The Directions for Use (DFU) promotes the following intended uses:

  • “One-Piece Neck Seal & Heat Tent […] Non-Invasive Ventilation (NIV)” [NIV]
  • “Start the ventilator in Pressure Support Ventilation with a PEEP of 5-7 cmH20 at least switching off the alarms for 2 minutes. [PSV]
  • “Use the device only with devices and appliances suitable to the Non-Invasive Ventilation (NIV) and Pressure Support Ventilation (PSV).” [PSV]

You have not submitted any new 510(k) in association with the statements made in the labeling of the Treatment Hood describing these new intended uses. The Treatment Hood as currently labeled is therefore misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not timely notify FDA of its intent to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of the Modified MCH Devices, as required by section 510(k) of the Act. Our inspection, including our review of your website, revealed that the Treatment Hood (hyperbaric chamber) is also 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g).

For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. 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.

The inspection revealed that your devices are also misbranded within the meaning of section 502(c) of the Act, 21 U.S.C. § 352(c), because a word, statement, or other information required by or under authority of section 519 of the Act, 21 U.S.C. § 360i, to appear on the label or labeling of the devices was not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In particular, 21 CFR 801.20(a), which was promulgated under authority of section 519 of the Act, among other provisions, requires, with exceptions not relevant here, that the label 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. The labels of the Sea-Long Medical Treatment Hood devices do not bear such a UDI. For example, the labels for these devices do not include a device identifier within the meaning of 21 CFR 801.3 or 830.3, there is no UDI presented in easily readable plain-text (see 21 CFR 801.40(a)(1)), and there is no UDI presented in machine-readable form that uses automatic identification and data capture (AIDC) technology (see 21 CFR 801.40(a)(2)).

In addition, your Sea-Long Medical Treatment Hood devices are 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 devices. In particular, 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. Your firm is a “labeler” within the meaning of 21 CFR 830.3 and has not submitted to GUDID any information required by 21 CFR Part 830, subpart E, respecting these devices.

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).

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 devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

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 to: Jessica Mu, Director of Compliance Branch, at oradevices3firmresponse@fda.hhs.gov. Refer to CMS 647320 when replying. If you have any questions about the contents of this letter, please contact: Linda Linh N. Adams, Compliance Officer, at (916) 930-3674 ext. 1111 or lindalinh.adams@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.

Regards,
/S/
Shari J. Shambaugh
Program Division Director
Office of Medical Device and Radiological Health
Operations Division 3/West

/S/

Dr. Malvina Eydelman
Director
OHT 1: Office of Ophthalmic, Anesthesia, Respiratory,
ENT & Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

 

Cc: Mr. Christopher L. Austin, President and Co-owner (via UPS)

_____________________

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