WARNING LETTER
Dexcowin Co. Ltd.
MARCS-CMS 545388 —
February 20, 2018
Recipient:
Recipient Name
Raymond Ryu
Dexcowin Co. Ltd.
606 Woolim Lions Valley II
Gansan-dong
Geumcheon-gu
Seoul
08591
South Korea
Issuing Office:
Center for Devices and Radiological Health
United States
10903 New Hampshire Avenue
Silver Spring, MD 20993
WARNING LETTER
February 20, 2018
VIA UNITED PARCEL SERVICE
Raymond Ryu
CEO
Dexcowin Co., Ltd.
606 Woolim Lions Valley II
Gansan-dong, Geumcheon-gu
Seoul 153-776
Republic of Korea
RE: FDA Reference Number: COR17000951
Dear Mr. Ryu:
During an inspection of your firm located in Seoul, Republic of Korea,on August 28, 2017, through August 31, 2017, an investigatorfrom the United States Food and Drug Administration (FDA) determined that your firm manufactures portable 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 responses from you dated September 18, 2017, October 24, 2017, and November 27, 2017, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address these responses below, in relation to each of the noted violations. Your response dated January, 31, 2018, to the Form FDA 483 (FDA 483) was not reviewed; the response will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter.  These violations include, but are not limited to, the following:
1.
Failure to establish and maintain adequate procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). Specifically:
a.
Your firm’s CAPA procedure, QP-806 “Corrective and Preventive Action”, Rev. 1, dated September 25, 2014, fails to require verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device. For 12 reviewed Corrective Action Reports in 2017, there was no documentation of verification or validation of the corrective and preventive action to ensure that such action was effective and does not adversely affect the finished device.
b.
Due to an influx of battery complaints, your firm switched battery suppliers. However, your firm did not process this corrective action through its CAPA system.
c.
Your firm’s CAPA procedure, QP-806 “Corrective and Preventive Action”, Rev. 1, dated September 25, 2014, Section 4.1.4 states that it is the quality management representative’s responsibility to “[r]eport to CEO the result of the action as management review agenda.” However, of the seven CAPAs processed in 2015, two CAPAs were not reported in the management review, and your firm has no justification otherwise.
We reviewed your firm’s responses and conclude that they are not adequate. The responses state that your firm plans to modify its CAPA procedure such that it matches 21 CFR 820.100, and conduct training accordingly.  Your firm plans to initiate a CAPA due to the battery complaints.  Additionally, your firm’s responses include plans to check the effectiveness of the twelve aforementioned CAPAs. Your firm’s responses reveal plans to include all 2017 CAPAs in your firm’s upcoming management review. However, your firm’s responses do not include a retrospective review of CAPAs to ensure they were processed per your firm’s procedure and the regulation, beyond the verification of effectiveness check.
2.
Failure to establish and maintain adequate procedures for validating the device design, as required by 21 CFR 820.30(g). Specifically, the design validation did not have predefined methods, operating conditions, acceptance criteria, to ensure the device conforms to defined user needs and intended uses, for the following metrics:
a.
(b)(4)
: the firm did not conduct validation to ensure that the X-ray tube conforms to defined user needs.
b.
X-ray exposures per battery charge:
(b)(4)
; the firm’s validation did not account for the worst-case scenario, the exposure with technique factors that would create the greatest drain on the battery.
c.
Remote control functionality: the firm’s validation consisted of testing
(b)(4)
with only
(b)(4)
exposure.
d.
X-ray field diameter:
(b)(4)
; the firm’s validation consisted of testing
(b)(4)
with
(b)(4)
exposure
(b)(4)
.
We reviewed your firm’s responses and conclude that they are not adequate.  The responses state your firm plans to revalidate the designs. However, your firm’s responses do not include a retrospective review of all designs to ensure the device conforms to defined user needs and intended uses.
3.
Failure to establish and maintain adequate procedures for 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). For example, the “
(b)(4)
Functional Evaluation Report”, dated August 21, 2015, documents verification of a design change (
(b)(4)
) for
(b)(4)
:
Per the report’s Section 1.1, the power input test was conducted at an exposure time of
(b)(4)
; however, no justification was documented to demonstrate this time as the worst-case scenario for highest power.
Per the report’s Section 3.1, exposure time accuracy was tested at exposure
(b)(4)
.  Per your firm’s CEO, Raymond Ryu, the test standard (which was not referenced in the report) requires exposure time test the device at the lowest exposure time.  However, the test was also
(b)(4)
was documented conducting the
(b)(4)
, the maximum exposure time for the device.
The report does not reference the standards followed for the testing.
Your firm has not maintained results for the testing conducted in support of the design change.
The report does not state the equipment that was used for testing.
We reviewed your firm’s responses and conclude that they are not adequate.  The responses state that your firm plans to revalidate the design, ensuring that the test correspond with the referenced standard, IEC 60601. Your firm’s responses do not include a retrospective review of other design changes to ensure that they were appropriately validated, or where appropriate, verified.
4.
Failure to adequately ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results according to established procedure, as required by 21 CFR 820.72(a). Specifically, your firm had no documentation that
(b)(4)
of testing equipment were qualified for their intended purpose per the associated standards.
We reviewed your firm’s responses and conclude that they are not adequate.  The responses state that your firm plans to qualify the testing equipment. However, your firm’s responses do not include an action plan for a corrective action to prevent the recurrence of the issue.
5.
Failure to establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services, as required by 21 CFR 820.50(b). For example, the approved supplier list documented grades of “
(b)(4)
”, for each supplier; the CEO, Raymond Ryu, was not able to provide a justification behind the identical ratings and evaluation of each supplier.
We reviewed your firm’s responses and conclude that they are not adequate. The responses state that your firm plans to modify “QP-803” to incorporate ongoing supplier evaluation and create a post evaluation form. Your firm’s responses include untranslated documents with the file names, 06) AS procedure.pdf, and 07) AS report form. Your firm’s responses do not include English translations of the documents.
Additionally, the responses do not include a retrospective review of all current supplier evaluations to ensure, where possible, written agreements are established such that suppliers are notifying your firm of changes in the product or service so that your firm may determine whether the changes may affect the quality of the finished device.
6.
Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). Specifically, your firm utilized
(b)(4)
document its device history record (DHR). However, the software was not validated to adequately document device information without any alteration, per an established protocol. For example, a technician was observed to be able to click pass and fail for the same test without error.
We reviewed your firm’s responses and conclude that they are not adequate.  Your firm’s responses state that your firm plans to validate the
(b)(4)
program for DHR use, and conduct training accordingly. However, your firm’s responses do not include a retrospective review of other automated process to ensure they are adequately validated for their intended use.
7.
Failure to maintain device history records (DHRs), and to establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained, as required by 21 CFR 820.184. Specifically, your firm’s procedure, QP-704 “Materials/Product Management”, Rev. 1, dated September 25, 2014, Section 3.3.3, states, “[t]he record of labeling inspector shall be written in DHR (Device History Record).” However, the DHR for device
(b)(4)
did not include the device label. Additionally, your firm’s procedure did not include other requirements for DHRs as specified in 21 CFR 820.184, such as the dates of manufacture, quantity manufactured, quantity released for distribution, acceptance records, and UDI.
We reviewed your firm’s responses and conclude that they are not adequate.  Your firm’s responses state that your firm plans to add the missing DHR information requirements to its procedure; however, the responses do not include such procedure. Your firm’s responses include a DHR form, with a field for the device label; however, the form lacks fields for the dates of manufacture, quantity manufactured, and quantity released for distribution.
8.
Failure to ensure that changes to documents shall be reviewed and approved, with maintaining change records including a description of the change, identification of the affected documents, signature(s) of the approving individual(s), approval date(s), and when the change becomes effective, as required by 21 CFR 820.40(b). Specifically, your firm’s procedure, QP-401 “Document Control”, Rev. 5, dated July 31, 2017, Sections 6.2.5 and 6.2.6, state, “[w]hen a quality document is revised or reissued, a change history shall record in the quality document management book so that the change history be known and manage[d].  [The] [c]hange record shall include what's changed, identification of changed document, signature and date of approval, and effective date of the change. However, your firm made updates to procedures on numerous occasions without documentation of the date the procedure was updated and the approval signature by a designated individual.
We reviewed your firm’s responses and conclude that they are not adequate.  The responses states your firm has modified the designated signatory from the CEO to the Chief R&D Director within the QP-401 “Document Control” procedure. Your firm’s response includes an untranslated document with the file name, (QP-401) Document Control_REV6.pdf. Your firm’s response does not include an English translation of the document.
Additionally, the response does not include a retrospective review (in English) of all quality system procedures to ensure document controls per your firm’s own procedure and 21 CFR 820.40.
9.
Failure to establish adequate procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). Specifically:
a.
Your firm’s procedure, QP-601 Education & Training, Rev. 7, dated August 29, 2017, Section 4.2.1, states “each team leader shall figure out [] need[s] [for] educat[ion] and train[ing] for the team members to perform [] tasks efficiently.”  However, your firm has not documented training needs or records
(b)(4)
procedures, including, but not limited to, QP-804 Nonconforming Product Management, QP-803 Measurement and Monitoring Management, QP-707 Production and Inspection Device Management, QP-706 Process Validation, QP-705 Process Control, QP-702 Design Management, and QP-404 Side Effects and Safety Management.
b.
Your firm’s procedure, QP-601 Education & Training, Rev. 7, dated August 29, 2017, Section 4.5.2, states that a quality auditor must have the following training, “completed ISO 13485 and 4 hours or more of in-company quality auditor education course; experience[] as outside/in-company auditor; more than one year of quality inspection work experience and who the managing director assigned.” However, your firm does not have documentation that any employees that meet the training requirements specified in the procedure, despite having conducted quality audits in 2015 and 2016.
We reviewed your firm’s responses and conclude that they are not adequate.  The responses state that your firm plans to develop employee-specific training forms as well as training reports. Additionally, your firm’s responses identify plans to make training requirements more stringent (e.g., requiring 8+ hours of the requisite education). Your firm’s responses include untranslated documents with the file names, Education & Training report(QP-703).pdf, Education & Training report(QP-709).pdf, QP-601 Education & Training (Rev 7).pdf; and Internal auditor education application.pdf. Your firm’s responses do not include English translations of the documents.
Additionally, the responses do not include a retrospective review (in English) of all training requirements to ensure that personnel have the necessary education, background, training, and experience.
10.
Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals, as required by 21 CFR 820.20(c). Specifically, your firm’s procedure QP-502 “Management Review”, Rev. 3, dated September 25, 2014, states that the CEO, management representative, and each team leader are responsible to attend management reviews. However, your firm does not have documentation of their attendance.
The adequacy of your responses cannot be determined at this time. The responses state your firm plans to modify the management review report form to include fields for attendees. Also, the responses state that your firm plans to re-document management reviews from 2015 and 2016. The responses state your firm plans to conduct the 2017 management review in accordance with this new plan. However, your firm’s responses do not include the supporting documentation to this effect.
Our inspection also revealed that your firm’s devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. §
352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting.  Significant violations include, but are not limited to, the following:
11.
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.
We reviewed your firm’s responses and conclude that they are not adequate.  Your firm’s responses state that your firm plans to establish new procedure QP-407 to address MDR and ARO reporting. However, your firm’s responses do not include an MDR procedure. Additionally, your firm’s responses do not include a retrospective review of complaints to ensure that MDRs are reported.
Your firm’s devices are also electronic products subject to compliance with Subchapter C of the Act, Electronic Product Radiation Control, the requirements at 21 CFR 1000-1005, and the performance standards at 21 CFR 1010, 1040.10, and 1040.11.  Your firm failed to comply with the regulations regarding reporting and recordkeeping.
12.
Failure to establish and maintain adequate records of the results of tests for electronic product radiation safety including the methods, devices, and procedures used in such tests, as required by 21 CFR 1002.30(a)(2). Specifically, the Product Inspection Standard (Document #FI-02, rev 7, dated April 19, 2017), provides the requirements for testing each DX3000 Portable X-ray System to ensure the devices conform to Performance Standard 21 CFR 1020; however, the procedure fails to provide complete instructions on how to conduct and document the tests.
The adequacy of your firm’s responses cannot be determined at this time.  Your firm’s responses describe plans to add leakage radiation test methods to both FI-02 and the DHR and to train employees who are related to the work. However, the responses do not include samples of the revised documents and the proposed training records.
13.
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, your firm received the following two complaints and determined after receiving the returned devices, that they were operating correctly. However, your firm did not submit Reports of Accidental Radiation Occurrence (ARO), despite acknowledging that the patients most likely received accidental radiation exposure for the following complaints:
(b)(4)
, dated 2016-05-25, which states “X-RAY is not generated”
(b)(4)
, dated 2016-07-11, which states “X-RAY is not exposed”
We reviewed your firm’s responses and conclude that they are not adequate. Your firm’s response describes plans to establish a new procedure (QP-407) which includes ARO procedures, manage documents related to each report, and to train employees who are related to the work. These responses are not adequate because they do not include a retrospective review of past complaint records to determine if additional Accidental Radiation Occurrences have failed to be reported. Further, the two reportable events outlined in
(b)(4)
still have not been reported.  The responses did not include a retrospective review of complaint records and report any Accidental Radiation Occurrences including, at a minimum, the two occurrences identified in Observation 16.  If the retrospective review does not encompass all complaint records, then justification for the scope of this retrospective review should be included.
Given the serious nature of the violations of the Act,
the
portable dental diagnostic X-ray devicesmanufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated.  As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter.  We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to
verify that the appropriate corrections and/or corrective actions have been made.
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.
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 (OIR/DRH/DXRS)
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
Refer to FDA Reference Number COR17000951
when replying. If you have any questions about the contents of this letter, please contact LCDR David Dar, via telephone or email, at +1(301
)796-5617 or
david.dar@fda.hhs.gov
, respectively.
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 yours,
/S/
Donald St. Pierre
Director, Acting
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
CC:
Claude Berthoin
U.S. Agent
Denterprise International, Inc.
110 East Granada Boulevard, Suite 207
Ormond Beach, Florida 32176
Joyce@510kfda.com
Content current as of:
03/13/2018