- Nuga Medical Co., Ltd.
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire A venue|
White Oak Building 66
Silver Spring, MD 20993
DEC 24, 2014
VIA UNITED PARCEL SERVICE
Jong Soo Lee
Nuga Medical Co., Ltd.
Gwangju City, Gyeonggi-Do
Republic of Korea
Dear Mr. Lee:
During an inspection of your firm located at 73-1 Daessangryeong-Ri, Chowol-Myon, Gwangju City, Gyeonggi-Do, Republic of Korea, on August 25, 2014, through August 28, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures NM-7000, NM-2500, and NM-90 therapeutic heating and massaging 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. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example, your firm’s design control procedure, (b)(4), does not ensure devices conform to defined user needs and intended uses. Specifically:
a. There are no requirements for documenting investigations of failures that occur during design validation.
b. Your firm has not investigated design validation failures for the NM7000 heat and massage therapy table, which occurred between January 17, 2012, through January 27, 2012.
2. Failure to establish and maintain procedures for implementing corrective and preventive action, to include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a). For example, your firm’s corrective and preventive action (CAPA) procedure, (b)(4), requires CAPAs to be opened following data analysis, when issues are identified as requiring action. However, your firm failed to open CAPAs for six of sevenquality issues identified as needing investigation.
3. Failure to maintain complaint files, and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, to ensure that complaints are evaluated to determine if they represent events that must be reported to FDA under 21 CFR Part 803, Medical Device Reporting, as required by 21 CFR 820.198(a). For example:
a. Your firm’s complaint handling procedure, (b)(4), does not include requirements to ensure that complaints are evaluated for reportability.
b. Your firm received seventy threecomplaints for the NM-90 heating belt, involving melting and/or sparking at the connector. However, your firm failed to evaluate these complaints for reportability.
4. Failure to establish and maintain procedures for verifying the device design, as required by 21 CFR 820.30(f). For example:
a. Your firm failed to provide verification procedures and reports/data for the temperature shutdown functionality of the NM-7000 device.
b. Your firm’s temperature shutdown verification test utilizes a (b)(4) to measure whether the current has ceased. Your firm failed to provide documentation that the test equipment is qualified. Your firm also failed to provide documentation that shows that the design output meets the design input requirements.
5. Failure to establish and maintain 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, your firm has not implemented and recorded design changes and design change validation activities according to your firm’s design control procedures, (b)(4), for the following:
a. Your firm did not implement and document a change in the type of fuse needed during the design validation, conducted in January 2012, of the NM7000 heat and massage therapy table.
b. Your firm changed the design of the connector shape for the NM-90 heating belt from square to round, as noted in CAPA 140411-001, to address melting and/or sparking at the connector. Your firm has distributed devices with this change to five customers. According to your firm representative, your firm has not established a validation protocol for this change.
6. Failure to establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met, as required by 21 CFR 820.80(c). For example, your firm’s in-process production testing records dated August 25, 2014, August 26, 2014, and August 27, 2014, contained pre-filled values for the reject quantity, prior to conducting the testing for the NM 5000P devices.
7. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to specifications, such that where process controls are needed, they shall include the approval of processes and process equipment, as required by 21 CFR 820.70(a). For example, your firm installed (b)(4) manufacturing equipment which included an (b)(4) and (b)(4). However, your firm has not performed and documented the activities related to installation and operational qualification of the (b)(4) manufacturing equipment, as required by your firm’s process validation procedure, (b)(4).
8. Failure to document activities required under 21 CFR 820.100, and their results, as required by 21 CFR 820.100(b). For example, your firm failed to document the temperature regulator investigation and testing of the NM-90 heating belt for CAPA 120217-001.
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 regarding the devices that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR). Significant violations include, but are not limited to, the following:
9. Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, your firm stated that it does not have a written MDR procedure for reporting adverse events to the US FDA.
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements:
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov
Given the serious nature of the violations of the Act, devices manufactured by your firm, includingNM-7000 massage and heating table, NM-2500 heating pad, and NM-90 heating belt, 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 and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
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 action (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. We will notify you regarding the adequacy of your firm’s response and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #446005. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch at telephone +1 (301) 796-5587, or fax +1 (301) 847-8139.
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.
Steven D. Silverman
Office of Compliance
Center for Devices and