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WARNING LETTER

Denterprise International, Inc. MARCS-CMS 586932 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices
Recipient:
Denterprise International, Inc.

100 E. Granada Blvd. Ste. 219
Ormond Beach, FL 32176
United States

Issuing Office:
Division of Medical Device and Radiological Health Operations Central

United States

WARNING LETTER
CMS# 586932

October 9, 2019

Dear Mr. Berthoin:

The United States Food and Drug Administration (FDA) conducted an inspection of your firm's medical device operations at Denterprise International, Inc., 100 E. Granada Blvd. Ste. 219, Ormond Beach, Florida, from May 1, 2019 to May 6, 2019. During the inspection, an FDA investigator determined that your firm is a specifications developer, manufacturer of the FlashRay dental X-ray sensor and the MobileX, Model T-100, dental X-ray system. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 32l(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.

This inspection revealed that these devices are adulterated within the meaning of section 501 (h) of the Act, 21 U.S.C. § 35 l(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 June 3, 2019 from W. Lee Strong, Jr., Quality Management Systems Representative concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued on May 6, 2019. We address the response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Although not appearing on the Form FDA 483, failure to establish procedures for design control, as required by 21CFR820.30(a). Specifically, your firm has not established and maintained procedures to control the design of your FlashRay dental Xray sensor device to ensure specified design requirements are met. For example,

A. Procedures for design inputs have not been established, as required by 21 CFR 820.30(c), including procedures to ensure the design requirements are appropriate and address intended use of the device, including the needs of the user and patient.
B. Procedures for design outputs have not been established, as required by 21 CFR 820.30(d), including procedures containing acceptance criteria and those design outputs essential for the proper functioning of the device.
C. Procedures for design review have not been established, as required by 21 CFR 820.30(e).
D. Procedures for design verification have not been established, as required 21 CFR 820.30(f).
E. Procedures for design validation have not been established, as required by 21 CFR 820.30(g), including risk analyses to identify possible hazards associated with the design of your device in both normal and fault conditions.
F. Procedures for design transfer have not been stablished, as required by 21 CFR 820.30(h).
G. Procedures for design change have not been established, as required by 21 CFR 820.30(i).
H. Failure to establish and maintain a design history file (DHF) for each type of device, as required by 21 CFR 820.300).

The FlashRay dental X-ray sensor device is comprised of: (1) an intraoral detector which connects to a PC via a USB port ((b)(4)); and (2) an (b)(4) package (b)(4) . Denterprise International Inc. does not have a design history file to demonstrate the device design was developed in accordance to an approved design plan and all the requirements of 21 CFR 820.30.

This deficiency was previously communicated to Denterprise International, Inc. in our Letter dated 08/08/2018 and 12/07/2018.

We have included an FDA guidance document titled, "Design Controls for Medical Device Manufacturers" to assist in your corrections. We request that you review this document and 21 CFR Part 820.30 and provide a summary of your corrections related to the design controls of these products when you feel they are complete to meet the requirements of your procedure. These will be further reviewed as part of your next inspection.

2. Failure to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50(b). For example, your firm's Supplier Qualification Plan procedure, PROCPD-002, Issue No. 0.01 has not been adequately established and maintained to ensure the evaluation of suppliers on their ability to meet quality requirements. On April 4, 2018 your firm received premarket clearance 510(k) number K180561 for the MobileX, Model T-100, diagnostic X-ray system. This device is designed and manufactured by (b)(4). During our inspection of your firm, you were unable to provide our investigator with a design history file (DHF) for the MobileX, Model T-100, diagnostic X-ray system to ensure all requirements under 21 CFR 820.30 were met. In addition, you have not defined the type and extent of control that you will place on vendors and other received products and services based on the results of the evaluation.

During our inspection, your firm's Quality Systems Manager/Product Manager admitted that you have not implemented the requirements of your current Supplier Qualification Plan procedure in order to evaluate the (b)(4)., which is the company that designed and manufactures your MobileX, Model T-100 dental X-ray system. Denterprise International Inc. began distributing the MobileX, Model T-100 dental X-ray system in the U.S. during the summer of 2018.

We have reviewed your firm 's response and find it inadequate. Your firm's response included a revision to the Supplier Qualification Plan procedure to include specific vendor criteria that will be used in the evaluation of suppliers. Your firm did not provide evidence of the implementation of the revised purchasing controls to include the evaluation of your current suppliers.

This deficiency was previously listed to your firm during the FDA inspection of 03/07-12/2018 and on an Untitled Letter dated 08/08/2018.

3. Failure to include required information in complaint records, as required by 21 CFR 820.198(e). For example,

A. Your complaint records do not include the nature of the complaint with sufficient detail to fully support the findings of your investigation and the actions taken in response. For example, your complaint records do not accurately describe whether or not persons were exposed to additional radiation due to a device malfunction. Complaint records reviewed during the inspection identified device malfunctions that described additional radiation exposures. However, these were not reported as an accidental radiation exposure (ARO) to the FDA.

B. Your complaint records do not always include the date and results of the complaint investigation. For example, complaint records reviewed identified complaints that did not always include the date and details of the investigation.

We have reviewed your firm's response and find it inadequate. According your firm's response, each complaint case has been reviewed and revised to improve the documentation and the cause. Your firm's response states that you have (b)(4). Your firm has not conducted a review of previously entered complaints to ensure they contain sufficient detail to fully support the findings of your investigation which may affect your decision to submit a report to FDA.

This is a repeat deficiency from the FDA inspection conducted from 07/25-29/2016, 03/07-12/2018 and on an Untitled Letter dated 08/08/2018.

4. Failure to adequately establish procedures for quality audits, as required by 21 CFR 820.22. For example, you have not implemented your current Internal Audit Policy and Procedures, PROC- QA-007 to determine the effectiveness of your firm's quality system. During the inspection the investigator noted that your firm had not performed internal quality audits at the frequency required by your firm's Internal Audit and Policy procedure. The procedure does not ensure that all areas of your firm's quality system are audited.

We have reviewed your firm's response and find it inadequate. Your firm's response states that a (b)(4) would be to be completed by (b)(4). In addition, your firm revised the Internal Audit Plan PROC-QA- 007 to include QMS Audit Objectives. The revised internal audit procedure does not ensure the all areas of your firm's quality system are audited to determine its effectiveness.

This is a repeat deficiency from the FDA inspection conducted from 07/25-29/2016, 03/07-12/2018 and on an Untitled Letter dated 08/08/2018.

5. Failure to adequately establish procedures for acceptance activities, as required by 21 CFR 820.80(a). For example, your firm has not adequately defined documented and implemented finished device acceptance activities for the MobileX, Model T-100, diagnostic X-ray systems and the FlashRay, QuickRay, and UniRay dental Xray sensors.

A. There are no written finished device acceptance testing procedures for the MobileX, Model T-100, diagnostic X-ray system.

B. Acceptance criteria described in the Acceptance Test - Sensors procedure, PROC-TS-004, Issue No. 1.02, does not define what a "corrupt rows or columns". The procedure is used to accept and release the FlashRay, QuickRay, and UniRay dental Xray sensors.

We have reviewed your firm's response and are unable to determine the adequacy where no documents were provided for review. We acknowledge corrections to include: new PROC-TS-007 Acceptance Test- MobileX with corresponding log record to be completed for each Unit; revised PROC-TS-004 Acceptance Test-Sensors procedure to clarify "corrupt row or columns"; revised PROC-SR-Receiving procedure to verify labeling. We are unable to determine the implementation of your firm's corrective actions where no documents were provided for review. A follow-up inspection by FDA is necessary to verify compliance.

This is a repeat deficiency from the FDA inspection conducted from 07/25-29/2016, 03/07-12/2018 and on an Untitled Letter dated 08/08/2018.

6. Failure to establish and maintain procedures for device history records, as required by 21 CFR 820.184(e). For example, you do not have written procedures to ensure device history records are maintained covering each of your MobileX, Model T-100 dental Xray system that is manufactured at your facility. This includes the maintenance of records documenting the packaging and labeling that refer to the primary labels, instruction for use and labeling applied to or packaged with each such device.

We have reviewed your firm's response and are unable to determine the adequacy where no documents were provided for review. We acknowledge corrections to include: new PROC-TS-007 Acceptance Test - MobileX procedure; labeling change submitted to supplier for implementation; revised PROC-QA-002 Control of Documents to describe version control for User Manuals on USB Cards; revised PROC-SR-007 Product Packaging to describe records of USB Cards sent for each unit. We are unable to determine the implementation of your firm's corrective actions where no documents were provided for review. In addition, there are actions that are still in progress or for which a response update has not been provided and a follow-up inspection by FDA is necessary to verify compliance.

This is a repeat deficiency from the FDA inspection conducted from 07/25-29/2016, 03/07-12/2018 and on an Untitled Letter dated 08/08/2018.

Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations 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. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Our inspection also revealed deficiencies under 21 CFR Chapter 1, Subchapter J-Radiological Health. Significant deviations include, but are not limited to:

Failure to immediately report to the Director, CDRH, FDA, an accidental radiation occurrence reported to or otherwise known to you, involving a product introduced or intended to be introduced into commerce by you, as required by 21 CFR 1002.20(a). Specifically,

A. Your records for Complaint No. 00010291, opened 09/18/2018, states that the complainant alleged that use of your QuickRay HD dental X-ray sensor resulted in the program stopping and without saving the data and also lists that you determined there were sixteen (16) additional exposures with twelve (12) patients affected which were related to this alleged problem, but you have not reported to the agency about this additional X-radiation exposure.

B. Your records for Complaint No. 0000995, opened 06/18/2018, states that the complainant alleged that use of your QuickRay HD dental X-ray sensor resulted in the capture of "grainy images" and also states that you determined there were four (4) additional exposures related to this alleged problem, but has not reported to the agency about this additional X-radiation exposure.

C. Your records for Complaint No. 00010369, opened 10/18/2018, sates that the complainant alleged that use of your QuickRay HD dental X-ray sensor resulted in the capture of "white images" and also states that you determined there were two (2) additional exposures related to this alleged problem, but these have not reported to the agency as AROs.

We reviewed your firm's response dated May 29th, 2019 and conclude that it is not adequate. Your response states that the complaint described under 'A' above meets your minimum reporting requirement of 10 exposures per patient, and that you have filed a form FDA-3649 for it. You state that you have revised your firm's procedure for ARO reporting to include weekly review of oral complaints and reviewed your oral complaint process to clarify conditions for ARO and times for reporting. You state that you have increased the threshold for potentially injurious exposure and identified personnel to review each complaint and complete ARO reports within 30 days of incidence. However, per 21 CFR 1002.20, your firm is required to report all accidental radiation occurrences reported to you or known by you arising from the manufacturing, testing, or use of any product introduced or intended to be introduced into commerce by your firm. Please ensure that your firm conducts a retrospective review of all accidental radiation incidents and reports AROs in accordance with the regulations.

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 correct 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 all violations included in this Warning Letter.

If you have questions regarding any issues in this letter, please contact Compliance Officer, Rafael Padilla at 312-596-4212 or at rafael.padilla@fda.hhs.gov. Please send your reply electronically to Melissa Michurski, Director of Compliance Branch, at oradevices2firmresponse@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 the violations, and take prompt actions to correct the violations and bring the products into compliance.

Sincerely,

/S/

Blake Bevill, M.S.
Program Division Director
Office of Medical Device and Radiological Health
Division 2 - Central
 

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