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WARNING LETTER

Dexcowin Co. Ltd. MARCS-CMS 474468 —

Delivery Method:
VIA UPS
Product:
Medical Devices
Recipient:
Recipient Name
Raymond Ryu
Recipient Title
CEO
Dexcowin Co. Ltd.

680 #606, Woolim Lions Valley II
Gasan-Dong
Geumcheon-gu
Seoul
South Korea

Issuing Office:
Center for Devices and Radiological Health

United States

WARNING LETTER

August 11, 2015

Re: FDA Reference Number: COR15000147

Dear Raymond Ryu:

During an inspection of your firm located in Seoul, Republic of South Korea on March 23 2015 through March 26 2015, an investigator (or investigators) from the United States Food and Drug Administration (FDA) determined that your firm manufactures Dental Diagnostic X-ray Devices. 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 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. § 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 Raymond Ryu, CEO of Dexcowin Co., Ltd. dated April 10, 2015 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 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 adequate procedures for the verification of design changes before their implementation, as required by 21 CFR 820.30(i). For example:

The report "DX3000 2mA Functional Evaluation Report" (dated 03/02/11) documents verification of a design change (increase of current from 1 mA to 2 mA) made to the DX3000 Portable X-ray system. However, review of this report revealed the following deficiencies:

a. The report shows (b)(4) devices were tested, but there is no documentation to show how many X-ray shots were taken with each device to document.
b. Your firm verbally reported that a total of (b)(4) X-ray shots were taken with each device to evaluate the: a) power input, b) tube voltage and current, c) and exposure time and exposure time x current (mAs); however, the results summarized on the report only show averaged data and there is no evidence to demonstrate that all X-ray shots met the acceptance criteria.
c. Your firm did not maintain raw data for any of the tests conducted.
d. The Power Input test shows the acceptance criteria as "240W + 10%"; however, the results show the Power measured at (b)(4).

The response dated 4/10/2015 is not adequate. Your firm’s response included a statement of intent to:
a. Add the information about how many x-ray shots are taken with each device to the report.
b. Add all data which summarizes the results of (b)(4) x-ray shots.
c. Maintain raw data for all tests conducted.
d. Revise the wording of the acceptance criteria to clarify that the acceptance criteria of the power input test should be “below” 240W +10%. (Your firm stated that the word “below” was inadvertently left out of the acceptance criteria.)

However, evidence of implementation of the proposed correction was not supplied in the response. The 4/10/2015 response did not address this observation.

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

Specifically, your firm’s complaint handling procedure (Customer Claim Management, Document #(b)(4), dated 07/13/11) does not include a requirement to ensure that complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 (Medical Device Reporting (MDR)). For example, 6 out of 6 complaint records reviewed (Complaints #(b)(4), #(b)(4), #(b)(4), #(b)(4), #(b)(4), and #(b)(4)) did not contain documentation of MDR determination.

Furthermore, it was observed that your firm does not document all complaints. Complaints for products that are not returned to your firm (which are handled by a distributor) are not entered into the complaint handling system.

The response dated 4/10/2015 is not adequate in that there was no retrospective review of complaints received at the Korean facility or the distributor, to determine if any of the complaints contained events that are MDR reportable. Your firm has proposed a correction to add “MDR determination checklist” to the complaint handling procedure and to ensure that all complaints are documented by ensuring that after-sales services (e.g. battery replacement or product exchange) offered by overseas distributors will be reported to the head office. However, your firm did not include evidence of implementation of this correction with the response to FDA. Without this documentation in hand, FDA cannot make an assessment with respect to adequacy.

3. Failure to establish and maintain adequate procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient, as required by 21 CFR 820.30(c). For example:

The design inputs records for the DX3000 Portable X-ray system (Design Inputs Analysis, File #(b)(4) dated 12/12/04 and Product Specifications and Function dated 12/06/04) are incomplete because they do not include the following device requirements listed in the User Manual:

  • Target angle (19-20 degrees)
  • 300 X-ray shots per battery charge
  • Remote control
  • X-ray field (b)(4) round
  • Weight of body without battery: 1.8 kg

Furthermore, the design verification report dated 8/01/05 shows that your firm did not verify these requirements.

The adequacy of the response dated 4/10/2015 cannot be determined at this time. The response states that your firm will prepare a document to define the design input requirements listed above and the verification of these requirements by May 2015 – August 2015. However, your firm did not include documentation for the proposed corrections and your firm did not provide evidence of implementation with the response to FDA. Without this documentation in hand, FDA cannot make an assessment with respect to adequacy.

4. Failure to establish procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate the device has been manufactured according to the Device Master Record, as required by 21 CFR 820.184.

Specifically, your firm has yet to establish Device History Record procedures. Furthermore, 3 out of 3 Device History Records reviewed (for devices with Serial Numbers (b)(4), (b)(4), and (b)(4)) did not include the release authorized by the signature [and date] of a designated individual, and the primary identification label.

The adequacy of the response dated 4/10/2015 cannot be determined at this time. Your firm’s response states that they will establish Device History Record procedures by using a new “Device History Record form” which was provided as an attachment to FDA. The procedures will include the release authorized by the signature and the date of a designated individual, and the primary identification label in the form. However, your firm did not provide documentation of the new Device History Record procedures along with the response to FDA. Without this documentation in hand, FDA cannot make an assessment with respect to adequacy.

5. Failure to establish and maintain adequate procedures for identifying training needs and to ensure that all personnel are trained to adequately perform their assigned duties, and to document training, as required by 21 CFR 820.25(b). For example:

No records were provided to demonstrate that your firm’s Business Department Assistant Manager (identified to handle customer complaints) has been trained in your firm’s customer complaint handling procedure (Customer Claim Management, Document #(b)(4)).

The adequacy of the response dated 04/10/2015 cannot be determined at this time. The response states that your firm will conduct training for their Business Department Assistant Manager on the customer complaint handling procedure. However, your firm did not provide evidence of implementation of this training with the response to FDA. Without this documentation in hand, FDA cannot make an assessment with respect to adequacy.

Our inspection also revealed that your firm performed prohibited act(s) under section 538 and 21 CFR Subchapter J – Radiological Health. Under section 538 of the Act (21 U.S.C. § 360oo) it is unlawful for a manufacturer of electronic product radiation-emitting devices to perform prohibited acts as outlined within that section. Therefore you may not introduce any product into commerce which fails to comply with section 538 of the Act or the applicable sections of 21 CFR Subchapter J. Significant violations include, but are not limited to, the following:

1. Failure to establish and maintain records of the results of tests for electronic product radiation safety, including the control of unnecessary, secondary or leakage electronic product radiation, the methods, devices, and procedures used in such tests, and the basis for selecting such methods, devise, and procedures, as required by 21 CFR 1002.30(a)(2).

Specifically, the Product Inspection Standard (Document #(b)(4), dated 05/17/11) provides the requirements for testing each DX3000 Portable X-ray System to ensure the devices conform to Performance Standard 1020; however the procedure fails to provide complete instructions on how to conduct and document the tests. For example, it does not provide instructions on what equipment to use and how to use it, the number of exposures to be measured, where to document the results, or how to maintain the raw data.

Furthermore, 3 out of 3 Device History Records reviewed (for devices with Serial Numbers (b)(4), (b)(4), and (b)(4)) revealed:

a. The specified positions for leakage radiation measurements are not adequately established and maintained in the records. For example, the positions specified in the test report (Exhibit #18) are not the same as those specified in the Product Inspection Standard (Exhibit #20) and in the user manual (Exhibit #6) and;
b. Results for the compliance tests performed are not documented for each sample, only averaged values are provided and there is no evidence that all X-ray shots met the criteria; and
c. Raw data was not maintained.

The response dated 4/10/2015 is not adequate. The response states that your firm will modify the test criteria and test method for X-ray in daily production report in the following manner:
1. “Leakage radiation measurements are conducted in accordance with IEC 60601-1-3 29.204.3. Leakage radiation is measured at (b)(4) of the product. However, we will exclude the leakage radiation measurement at the rear of the product from tests because the rear of the product does not meet the following test criteria: any area of 100 cm^2 of which no principal linear dimension exceeds 20 cm.”
2. “We will take (b)(4) X-ray exposures with each device and document all results for each sample. We will also maintain raw data for the tests conducted.”

While the response to part a) of the observation addresses the lack of consistency of the testing method, your firm appears to misunderstand the requirement of 1020.30(k). Performing the leakage radiation test in this method will provide a lower assurance of device safety, as ceasing to perform leakage radiation tests at the rear of the product could reduce assurance of safety of the operator of this handheld x-ray device. Also, your firm did not provide documentation with the response to demonstrate that a new test procedure has been developed and implemented.

2. Failure to establish and maintain copies of all written communications between the manufacturer and dealers, distributors, and purchasers concerning radiation safety including complaints, investigations, instructions, or explanations affecting the use, repair, adjustment, maintenance, or testing of the listed product, as required by 21 CFR 1002.30(a)(4).

Specifically, your firm has yet to establish procedures for handling Accidental Radiation Occurrences (AROs) and Notification of Defects. During the investigator’s discussion with management, the Dexcowin Quality Certification and Team Leader stated your firm has not established procedures for handling AROs or notification of defects. The investigator explained that your firm needs to establish procedures for AROs and notice of defects in addition to training on this and all EPRC requirements.

3. Failure to submit an annual report for products requiring one, as required by 21 CFR 1002.13

For example, no annual reports were submitted in 2013 and 2014 for the DX3000 and ADX4000 portable X-ray systems. This is a repeat observation from the previous inspection dated 6/02/11 – 6/03/11.

The response dated 4/10/2015 is not adequate. The response states that your firm will submit an annual report for products requiring one every year from 2015, and that you will submit an annual report by August 2015. However, your firm has not yet submitted the annual reports. Without this documentation in hand, FDA cannot make an assessment with respect to adequacy. Additionally, your firm had prior knowledge of this EPRC requirement, as your firm was cited in their 2011 inspection, but have not yet complied with the 2013 and 2014 annual report requirement.

4. Manuals or instruction sheets which include a schedule of the maintenance necessary to keep the equipment in compliance with the regulations were not provided to purchasers, as required by 21 CFR 1020.30(h)(1).

For example, the User Manual for the DX3000 Portable X-ray system does not include the maintenance necessary to keep the devices in compliance with the Performance Standard Part 1020. The User Manual states that “[e]very year for safe use of product, safety check-up is necessary”; however, there are no further instructions or additional explanation as to what this “safety check-up” consists of.

The response dated 4/10/2015 is not adequate. The response states that your firm will add the following sentence to the device user manuals: “(b)(4).”

However, your firm’s additional wording does not provide an explanation of what the safety check “in a certified test organization” consists of. In addition, the revised pages of the user manual which describe necessary maintenance activities were not supplied in the response.

5. Failure to provide an adequate Warning label on the control panel that includes “maintenance schedules,” as required by 21 CFR 1020.30(j). For example, the current Warning label on the DX3000 Portable X-ray system (510(k) 133007) reads: “Warning : This X-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed.” On June 10, 2006, this regulation was revised to read: “Warning : This X-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed.”

Your response dated 4/10/2015 is not adequate because it did not address how your firm planned to gain compliance on all of the distributed DX3000 Portable X-ray systems that contain an inadequate Warning label, nor did your firm indicate how you plan to assure that future production of this device will receive the Warning Label that contains the revised language. Additionally, your firm did not provide a plan to evaluate your other devices (e.g. ADX4000 Portable X-ray system – 510(k) 134055) that are required to have this same Warning label.

Also, U.S. 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 deviations 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.

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, including 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. Please provide a translation of documentation not in English to facilitate our review.

Your firm’s response should be sent to:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: Diagnostic X-ray Systems Branch
Document Mail Center -- WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

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.

Should you have any questions or comments pertaining to this letter, please contact Laurel Burk at the above letterhead address, by telephone at (301)796-5933 or by email at Laurel.Burk@fda.hhs.gov. In any written follow-up response, please clearly reference FDA reference number COR15000147.

Sincerely yours,
/S/

Alberto Gutierrez, Ph.D.
Director
Office of In Vitro Diagnostics and
    Radiological Health
Center for Devices and Radiological Health

CC:

Dexcowin U.S. Agent
Claude Berthoin
Denterprise International, Inc.
110 E Granada Blvd., Suite 207
Ormond Beach, FL 32176

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