- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Medical Devices
Recipient NameYoung Bei Kwon
- DigiMed Corp
#311, Ace High-end Tower III, 371-50 Gasan-Dong
- Issuing Office:
- Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20903
November 8, 2016
Dear Young Bei Kwon:
During an inspection of your firm located in Seoul, KR on July 24, 2016 through July 27, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures DIOX-602, BIOX, and MINIX-V hand-held dental x-ray systems. 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.
Our inspection revealed that the 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. These violations include, but are not limited to, the following:
Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, during the inspection, your firm noted that the document titled (b)(4), was also your firm’s MDR procedure. After reviewing the referenced document we concluded that it does not contain information that would indicate it is an MDR procedure created in accordance with the requirements in 21 CFR 803.17. Specifically:
1. (b)(4) does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
a. There are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and the definition for the term “reasonably suggests,” found in 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
2. (b)(4) does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example:
a. There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
b. The procedure, as written does not specify who makes the decision for reporting events to FDA.
c. There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
3. (b)(4) does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
a. The circumstances under which your firm must submit supplemental or followup, 5 day reports and the requirements for such reports.
b. Although the procedure includes references to 30 day, 5 day reports, it does not specify calendar days and work days, respectively.
4. (b)(4) does not describe how your firm will address documentation and recordkeeping requirements, including:
a. Documentation of adverse event related information maintained as MDR event files.
b. Information that was evaluated to determine if an event was reportable.
c. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
d. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
Your firm should adjust its MDR procedure accordingly to include a process for submitting MDRs electronically in accordance with the Final Rule for electronic Medical Device Reporting (eMDR) published in the Federal Register on February 14, 2014. In addition, your firm will need to establish an eMDR account in order to submit MDRs electronically. Information about the Final Rule for eMDR and the eMDR set-up process can be found on the FDA website at:
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 awarding of contracts.
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. Please provide a translation of documentation not in English to facilitate our review.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures to control environmental conditions as required by 21 CFR 820.70(c). Specifically, procedures to control electrostatic discharge while soldering and inspecting printed circuit boards have not been established. For example, employees performing soldering, assembly, and inspection of the printed circuit boards for the dental x-ray systems were observed in each of the two manufacturing rooms. It was observed that none of the operators in either of the two manufacturing rooms were practicing any ESD controls (i.e. they were not grounded to their work tables). The Deputy General Manager was asked if they had an ESD procedure and he stated they did not.
The adequacy of the responses received August 17, 2016 and September 13, 2016 cannot be determined at this time. The responses provide evidence of the installation of grounded workstations and grounded wrist straps available to all manufacturing personnel. Also, the response included a revised version of the Process Control document (b)(4) which was updated to include requirements for the provision, use, and daily testing of ESD equipment. However, the response did not provide evidence of training to ensure that employees are aware of how and why to implement these newly created ESD procedures.
2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints as required by 21 CFR 198(a). For example:
a. Repairs for dental x-ray units that fall within the two year manufacturing warranty are not handled as complaints. Approximately 46 service repairs from 2015 and 2016 identified errors including “low kV”, “exposure time is delayed”, “not able to power on”, “low mA”, and “spark is occurred.” These errors were assigned causes including “battery error”, “HV tank error”, and “LCD error.” These service repairs should have been handled through the complaint handling system but were not.
The responses received August 17, 2016 and September 13, 2016 are not adequate. These responses provide a revised copy of the Customer Complaint Procedure (b)(4) which states that “All customers’ complaints will be treated as “Customer Complaint” regardless of the warranty period.” Also, the Customer Complaint Report form (b)(4) was revised to remove the option to identify the record as a “Service activity application” rather than a “Customer complaint application.” However, the response did not address the retrospective evaluation of past service repair records for devices that were within the warranty period so that they may also be handled by the existing complaint handling procedure.
b. Complaint records do not document an evaluation to determine whether the complaint represents an event which is required to be reported as a Medical Device Report (MDR). While the MDR reportability decision is included in the Customer Complaint Procedure (b)(4) this decision is not documented.
The responses received August 17, 2016 and September 13, 2016 are not adequate. These responses provide a revised copy of the Customer Complaint Report form (b)(4) which was revised to include a space to document the MDR evaluation decision. However, the response did not address the retrospective evaluation of past complaint records (and service repair records) for MDR reportability
3. Failure to establish and maintain adequate procedures for validating the device design as required by 21 CFR 820.30(g). Specifically, the design validation report, Clinical Evaluation Report, Report No.:(b)(4) was inadequate and incomplete in that:
a. the validation protocol did not have predefined acceptance criteria, and
b. the validation protocol did not evaluate the acquisition of dental x-ray images on film using the film exposure preset settings
The responses received August 17, 2016 and September 13, 2016 appear to be adequate. The responses provided a revised validation protocol for use in the Clinical Evaluation Report which includes predefined acceptance criteria including quantitative (bench testing) and qualitative (clinical) endpoints. The new validation protocol also extends the evaluation to include use with x-ray film. This revised validation protocol was performed and documentation was provided to document that the device meets the predetermined acceptance criteria
4. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements including the evaluation of the need for investigation as required by 21 CFR 820.90(a). Specifically, the firm’s procedure, Non-Conforming Product Management (b)(4) does not require nonconformances to be either investigated, or if the decision is not to investigate, then document the reason why an investigation is not needed.
The responses received August 17, 2016 and September 13, 2016 are not adequate. The responses outline plans to revise the Non-Conforming Product Management procedure to require nonconformances to be either investigated, or if the decision is to not investigate, then document the reason why an investigation is not needed. The responses also included documentation of investigations for the two nonconformances cited in the observation which had occurred but were not provided during the inspection. However, the responses did not address a retrospective review of nonconformances prior to 2015 where either an investigation should have been performed, or justification should be documented, but were not. Further, the responses did not provide documentation of the revised Non-Conforming Product Management procedure.
5. Failure to establish and maintain adequate procedures to ensure that inspection, measuring, and test equipment is routinely calibrated as required by 21 CFR 820.72(a). For example:
a. The Fluke multi-function meters (b)(4) require calibration once a year but are performed every other year. These multi-function meters are used to perform all the final inspection tests.
The adequacy of the responses received August 17, 2016 and September 13, 2016 cannot be determined at this time. The responses described plans to calibrate the meters every year, included documentation of calibration of one of the two meters, and outlined plans to send the second meter to the manufacturer for calibration. However, a revised version of the calibration schedule was not provided to document that these multi-function meters are to be calibrated every year.
b. The Nichinis Vacuum Emergent Device, (b)(4) used to flush oil into the high voltage tanks and create the vacuum seal is not on the calibration list despite having three thermometers and two pressure gauges. The owner’s manual did not include a recommended calibration schedule and one was not established by your firm.
The responses received August 17, 2016 and September 13, 2016 are not adequate. The responses provided a calibration invoice from (b)(4) well as a receipt for the calibration of the thermometer and vacuum meter. However, the responses did not address the calibration schedule to ensure the continued calibration of these devices
6. Failure to establish and maintain adequate procedures to ensure that Device History Records for each unit are maintained to demonstrate that the device is manufactured in accordance with the DMR as required by 21 CFR 820.184. Specifically, the firm does not have a procedure for maintaining device history records. There are multiple inspection records for each dental x-ray unit but there is no device history record that either includes all this information or references the location of this information. Also a copy of the labeling is not included with the inspection records for each dental x-ray unit.
The responses received August 17, 2016 and September 13, 2016 are not adequate. The responses provided a revised version of the Process Inspection Report which now includes a space to attach a copy of the primary label. However, this DHR still does not identify the date(s) of manufacture as required by 21 CFR 820.184(a) and the responses did not address the inclusion of in-process records into the DHR.
Your firm’s response should be sent to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
ATTN: Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
Document Control 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.
Please refer to CMS 509750 and COR16000420 when replying. If you have any questions about the contents of this letter, please contact: LT Scott Gonzalez at Scott.Gonzalez@fda.hhs.gov or (301) 796-5889.
Alberto Gutierrez, Ph.D.
Office of In Vitro Diagnostics
and Radiological Health
Center for Devices and Radiological Health