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WARNING LETTER

Vitang Technology LLC MARCS-CMS 653455 —


Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Medical Devices

Recipient:
Recipient Name
Ronald Jiang
Recipient Title
Owner & CEO
Vitang Technology LLC

14662 Franklin Ave Ste H
Tustin, CA 92780-7224
United States

ron@vitangtechnology.com
Issuing Office:
Center for Devices and Radiological Health

United States


WARNING LETTER

CMS # 653455

June 12, 2023

Dear Mr. Jiang:

During an inspection of your firm, Vitang Technology LLC. (Vitang or “the firm”), located in Tustin, CA on January 24, 2023 through January 31, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer and distributor of The UniSmile Clear Aligner, a Class II dental aligner, cleared under 510(k) K191837and marketed as both the “UniSmile Clear Aligner System” and “2usmiles” on your firm’s websites. For example, your website (https://unismile.us/) promotes the device name Unismile. Additionally, your website (https://www.2usmiles.com/) promotes the device name 2usmiles. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), the UniSmile Clear Aligner System is a device because it is 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 function of the body.

We received your response, dated February 20, 2023, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address the response below, in relation to each of the noted violations, and any additional responses will be reviewed as part of your warning letter response.

Misbranded and/or Unapproved Device Violations

Our inspection revealed that your firm currently holds a 510(k) clearance for the “UniSmile Clear Aligner System.” This device was cleared on January 30, 2020, under K191837 for, among other things, treatment of tooth malocclusion in patients with permanent dentition by way of continuous gentle force. Your 510(k) summary dated January 29, 2020 states that “Software is used to design treatment plans. The software used with UniSmile Clear Aligner System is the Orchestrate 3D (K181112) software, version OrthoRx 4”.

Our inspection revealed that your firm made changes to the device without submission of a new 510(k). On November 26, 2019 you changed from using the cleared Orchestrate 3D to the non-cleared iRok OrthoRx 4.0 for the development of the treatment plans for your UniSmile Clear Aligner System. You indicated that you performed verification and validation activities on iRok OrthoRx 4.0 and concluded that this software is “similar in designing clear aligner treatment plans” as Orchestrate 3D (K181112). However, note that verification and validation requirements apply for all devices subject to 21 CFR 820.30, and must be conducted regardless of whether submission of a new 510(k) is required. A change in orthodontic treatment planning software is a change that could significantly affect the safety and effectiveness of the device within the meaning of 21 CFR 807.81(a)(3). Specifically, a change from Orchestrate 3D to iRok OrthoRx 4.0 has the potential to affect the proposed treatment protocol as well as the dimensions, configurations, and applied forces of the UniSmile Clear Aligners, and affect the clinical outcome. Accordingly, your firm was required to submit a new premarket notification submission under section 510(k) of the Act, 21 U.S.C. § 360(k), to FDA at least 90 days before you proposed to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of the modified UniSmile Clear Aligner System. You did not submit any new 510(k) for the referenced modification to the UniSmile Clear Aligner System.

Therefore, your devices are misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). Your devices are 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 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) of the Act, 21 U.S.C. § 360(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.

Quality System Regulation (QSR) Violations

Our inspection also revealed that the UniSmile Clear Aligner System is 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 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. These violations include, but are not limited to, the following:

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

Specifically, our inspection revealed that your firm has failed to establish and maintain procedures for (1) determining whether a complaint is reportable to the FDA under part 803, (2) investigating the possible failure of a device to meet any of its specifications, and (3) receiving complaints outside of your firm's complaint management system, including oral complaints. Instead, your procedure, Customer complaints and refinements, is used to only to provide refinement services, (e.g., rescans). For example, 11 out of 13 complaint records reviewed during our inspection did not include an evaluation for MDR reportability nor an evaluation to determine if an investigation was necessary. In addition, you did not perform an investigation into reports of broken aligners.

We reviewed your firm’s response, and it is inadequate. Although you stated that you recognize that your procedure lacks specific steps to report death or serious injuries, and that you will review and update procedures to comply with MDR reporting requirements within 6 weeks of your response and conduct training, you have not provided evidence of the corrective and preventive actions. Further, your response is also inadequate because it did not address corrective actions that you have taken or plan to take to establish procedures for investigating the possible failure of a device to meet any of its specifications or receiving complaints outside of your firm's complaint management system, including oral complaints.

2. Failure to validate software used as part of the quality system for its intended use according to an established protocol, as required by 21 CFR 820.70(i).

Specifically, you failed to validate your complaint handling system software. Your Ruby on Rails server-side web application framework, using the programming language Ruby and found at unismile.us, is used to maintain complaint files. However, your firm has failed to validate the software for its intended use.

We reviewed your firm’s response and concluded that the adequacy of your firm’s response cannot be determined at this time. In your response, your firm stated that your complaint handling system has been in use for a few years and has “proven to be effective.” However, your firm has not provided evidence of the effectiveness of this complaint handling system. Additionally, your firm stated that you initiated an action plan to validate the complaint handling system. You committed to generate a software validation report, approach, testing methodology, and results of the validation within 6 weeks of your response to FDA. You have not provided a response with evidence of the corrective and preventive actions relevant to the complaint handling system effectiveness.

3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, including evaluation of suppliers, contractors, and consultants, as required by 21 CFR 820.50(a).

Specifically, you are not defining the type and extent of control to be exercised over supplier services. When our investigator asked for an evaluation of your firm’s suppliers, you only provided a Manufacturing and Supply Agreement with Xi’an Henghui Technologies Co., Ltd. The August 27, 2021, manufacturing agreement with Henghui, the Chinese contract manufacturer and supplier for the uncleared software you use in the design of the dental aligners, does not identify the roles and responsibilities of both companies. Henghui has contract manufactured your devices since 2019.

We reviewed your firm’s response and concluded that the adequacy of your firm’s response cannot be determined at this time. You stated that you conducted comprehensive inspections of your critical supplier, Henghui, including site visits, and documented the results. You stated to look at an Attachment A. However, the response did not contain an Attachment A. Further, all supporting documents in the response are in Chinese and cannot be reviewed or assessed. You stated that you plan to review the supplier evaluation process and update necessary documents as soon as possible, and conduct auditing of all suppliers, within 12 weeks of the response. You have not provided a response with evidence of the corrective and preventive actions.

4. Failure to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR § 820.75(b), and failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure, including the validation of major equipment, as required by 21 CFR 820.75(a).

Specifically, your Validation of Process procedure refers to “approval of equipment” but does not address equipment qualification to show that equipment is appropriately designed, constructed, placed, and installed. You stated during the inspection that you have documents in Chinese from the supplier that show the installation and qualifications of your 3D printer. However, since they were not in English, we were unable to verify this statement nor if your firm validated the 3D printing process used to manufacture the UniSmile Clear Aligner System. In addition, your firm’s General Manager and Engineering Manager stated that your firm documents the installation of the printers and the operational and performance qualification in the HeyGears Ultracraft A2D Quasi-Industrial Grade DLP 3D Printer operation manual when an installation occurs. However, that manual does not indicate when the qualification occurred or include evidence that it was performed.

We reviewed your firm’s response and concluded that your response is inadequate. Your firm has not provided a procedure that addresses major equipment qualification or process validation for your 3D printing process. You stated that you will complete the necessary updates to the equipment qualification documents for all equipment within 12 weeks of the response and conduct training. We request that you provide evidence that your 3D printing process has been qualified and validated.

5. Failure to adequately establish and maintain procedures to ensure equipment is routinely calibrated, inspected, checked, and maintained as required by 21 CFR 820.72(a).

Specifically, the Equipment Calibration List in your firm’s Control of Monitoring and Measuring Equipment’s procedure states that the 3D Printer should be calibrated monthly, but your firm could only provide a record of quarterly maintenance. You are not documenting the next calibration due date for your 3D printers used in the manufacture of dental aligners. Records are not readily available to the personnel using such equipment as you do not keep the records at the firm. Instead, your firm stated that they are kept with the 3D printer supplier/calibrator.

We reviewed your firm’s response and concluded that the adequacy of your firm’s response cannot be determined at this time. You stated that the equipment has been calibrated but, due to a manpower shortage, some of the records were not available. You also stated this was compounded by deficiencies in forms and procedures. You stated that you will review your forms and procedures relating to calibration and update as necessary within 10 weeks of the response. You have not provided calibration records to show all equipment was calibrated on the required schedule and have not provided a response with evidence of the corrective and preventive actions.

6. Failure to establish procedures for device history records as required by 21 CFR 820.184.

Specifically, your firm does not have a device history record (DHR) procedure. For example, a review of 11 out of 13 device history records (DHRs) for dental aligners did not include nor make reference to the primary identification label and labeling used for each production unit. In addition, the device history records do not contain any UDI information on its label or labeling. During our inspection, you stated that the procedure is being held at the supplier in China.

We reviewed your firm’s response and concluded that the adequacy of your firm’s response cannot be determined at this time. You stated that you reviewed Henghui’s procedures and quality documents and deemed them equivalent to your firm’s procedure in Attachment B. You stated that you can obtain documents from Henghui upon request and then referenced an Attachment C. Both attachments are in Chinese, and we are unable to review them. You stated that the DHR does not include or refer to the location of any UDI or UPC as you believed the devices were custom-made and exempt. In your response you stated that you plan to conduct a review and update of device history process procedures with 8 weeks of the response and provide guidance to all employees; and you will review and update shipping documentation within 4 weeks of the response and then conduct training. You stated that you will update your DHRs with regard to UDI/UPC within 6 weeks of the response and provide training to employees.

7. Failure to document the results and/or dates of management reviews as required by 21 CFR 820.20(c).

Specifically, you firm has no record of management reviews. Your Quality Manual and Management Responsibility documents both make references to the required conduct of management reviews. You provided a memo on 01/30/2023 that they have been conducted. However, it is generalized as to the topics covered and there are no dates of reviews documented.

Your firm’s response is inadequate because it does not address this observation.

8. Failure to document personnel training as required by 21 CFR 820.25(b).

Your firm has failed to document training records. Specifically, you were unable to provide training records for General/Engineering Manager and the CEO/Vice President of Operations/Head of Shipment Tracking and Handling.

However, your procedure that we did review indicates that new employees attend an orientation that includes training on the quality system, the quality policy, the importance of meeting regulatory, statutory and customer requirements, and the relevance and importance of their activities and how they contribute to the achievement of the quality objective. However, there is no documentation of this orientation.

Your firm’s response is inadequate because it does not address your firm’s failure to document personnel training.

Representations that Create an Impression of FDA Approval

The UniSmile Clear Aligner System is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because a representation on your website creates an impression of official approval of the device and is misleading. In addition, 21 CFR 807.97 states that any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding. Your website contains such representations. Specifically, your website at https://www.2usmiles.com/why-2usmiles states: “FDA APPROVED.” and incorporates the FDA logo. Statements about having active status with the FDA, and display of the FDA logo near images of and information about the respective products, is misleading because such information implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the products and/or establishments. Such representations are especially concerning from a public health perspective because consumers rely on information provided by sellers to determine whether to purchase a device and your presentation conveys the misimpression that the products have been reviewed and approved by 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 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.

In addition, we offer the following comment:

  • We note that we are unable to identify whether the device covered by the above-referenced 510(k) clearance is the same as the 2usmiles your firm is currently marketing. We request that you provide to us in writing with your firm’s basis for determining the 2usmiles is the same device described in K191837.

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 implantation 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. Please provide a translation of documentation not in English to facilitate our review. 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 # 653455 when replying. If you have any questions about the contents of this letter, please contact: Raymond W. Brullo, Compliance Officer at 949-608-2918 or 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/

Malvina B. Eydelman, M.D.
Director
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

/S/

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

 
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