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WARNING LETTER

Won Industry Co. LTD MARCS-CMS 582071 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices

Recipient:
Recipient Name
Ji Hoon Yang
Recipient Title
President & CEO
Won Industry Co. LTD

7-12 Bangadari-Gil
Siheung-si
Gyeonggi-do
14901
South Korea

Issuing Office:
Center for Devices and Radiological Health

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States



WARNING LETTER

August 29, 2019

Dear Mr. Yang:

During an inspection of your firm located in Siheung-si, Republic of Korea from April 8, 2019, through April 11, 2019, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Morning Life Compression Limb Therapy System. 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, which was a follow-up to an inspection conducted from October 12, 2015, through October 15, 2015, 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 Min Seo, a representative from the Overseas Business Department of your firm, dated May 16, 2019, 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 this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).

Your firm has not investigated the root cause of all deficiencies in your Corrective and Preventive Action (CAPA) procedure, design validation procedure, medical device reporting procedure, complaint handling procedure, device history record procedure, and other quality system deficiencies identified in FDA-483 issued to your firm’s management on October 15, 2015. Not all distributed products, complaints, CAPAs, and other quality system issues that potentially have been affected by these quality system deficiencies have been analyzed to identify existing and potential causes of nonconforming product, or other quality problems. For example, (b)(4), your firm’s CAPA procedure, includes nonconformities identified by external organizations as a corrective action data source. However, your firm has not investigated all deficiencies and nonconformities identified in the previous FDA-483.

Additionally, your firm has not performed verification or validation of CAPA 2017.03.20 and CAPA 2017.03.21, which were opened to prevent distribution in the U.S. of class II medical devices with no valid 510(k)s, to ensure actions taken were effective.

This observation is a recurring observation from the previous inspection.

We reviewed your firm’s response and conclude that it is not adequate. Your firm stated that you revised your guidelines to fit FDA’s requirements for CAPA and provided a revised CAPA Report that includes the following sections for input and evaluation: Nonconformity Detected, Initiate NC_CA, Cause, Risk Assessment, Corrective Action, Verification Validation Result, Implementation, and Post Implementation Report. Your firm also provided CAPA Reports generated to address the observations from this inspection and also provided a CAPA Report for Observation 1A from the previous October 2015 inspection, which included information regarding verification and validation conducted by your firm for that particular CAPA. However, you did not provide evidence that you investigated all of the deficiencies identified from the previous 2015 inspection and conducted verification or validation to ensure any actions taken were effective. Additionally, your firm did not address any plans to conduct a retrospective analysis of other potential nonconformities associated with each respective observation from the previous inspection.

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

For example, your firm’s complaint handling procedure, (b)(4), does not require evaluation of complaints for medical device reporting under 21 CFR Part 803. Additionally, (b)(4) does not require recording unique device identifiers or the complainant’s phone number and address in complaint investigation records.

This observation is a recurring observation from the previous inspection.

We reviewed your firm’s response and conclude that it is not adequate. Your firm revised (b)(4), to include a statement indicating that the sales manager will check with (b)(4) to decide if the complaint needs to be reported to the FDA. However, your firm did not include a description of the information required to be included in the complaint investigation records. Additionally, your firm did not address any plans to conduct a retrospective analysis of other complaints to determine if there are other instances where complaints were not properly reviewed and evaluated for Medical Device Reporting (MDR) reportability.

3. Failure to adequately establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of this part, as required by 21 CFR 820.184.

For example, your firm stated that it does not have a written DHR procedure. Additionally, after review of the DHRs for the (b)(4) and (b)(4) models of the Morning Life Compression Limb Therapy System, it was discovered that your firm does not include a primary identification label or unique identifier (UDI) of the finished devices.

This observaton is a recurring observation from the previous inspection.

We reviewed your firm’s response and conclude that it is not adequate. Your firm revised document (b)(4), Record Management, to include requirements to retain the primary identification label and UDI of the finished devices as part of the DMR; however, the entire procedure was not provided for review. Additionally, your firm did not address any plans to conduct a retrospective analysis of other DHRs to determine if there are other instances where DHRs were not properly maintained.

Our inspection also revealed that your firm’s Morning Life Compressible Limb Therapy System 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, your failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, your firm has not established procedures for the timely and effective identification, communication, and evaluation of reportable events; the timely transmission of medical device reports to FDA; or for compliance with the applicable documentation and record keeping requirements.

This observation is a recurring observation from the previous inspection.

We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that you revised document (b)(4), Monitoring System (b)(4), to include FDA’s MDR requirements; however, the entire procedure was not provided for review. Additionally, after reviewing the information provided, the following issues were noted:

1) 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,” and “serious injury,” and the definition for the term “reasonably suggests,” found in 21 CFR 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), Monitoring System (b)(4), does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the circumstances under which your firm must submit initial 30 day, supplemental and follow-up, and 5-day reports and the requirements for such reports was not addressed.

3) (b)(4), Monitoring System (b)(4), does not describe how your firm will address documentation and record-keeping requirements, including:

a. Documentation of adverse event related information maintained as MDR event files.

b. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.

Please note that (b)(4), Monitoring System (b)(4), does not discuss the submission of MDRs electronically. Effective August 14, 2015, MDRs should be submitted to the FDA in an electronic format that the FDA can process, review and archive. Paper submissions will not be accepted, except under special circumstances directed by the 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:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/eMDR%E2%80%93ElectronicMedicalDeviceReporting/default.htm

Given the serious nature of the violations of the Act, the Morning Life Compressible Limb Therapy System devices manufactured 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. Your firm was placed on Import Alert 89-08 “Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)” as a result of the violations outlined in the Warning Letter issued to your firm on December 16, 2016. Because FDA’s 2019 inspection of your firm resulted in repeat observations, you firm will now be placed on Import Alert 89-04 “Detention Without Physical Examination of Devices from Firms that Have not met Device Quality System Requirements.” 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: Food and Drug Administration, Center for Devices and Radiological Health, Office of Regulatory Programs, Division of Regulatory Programs 2: Establishment Support, Regulatory Inspections and Audits Team, White Oak Building 66, Rm 3657, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #582071 when replying. If you have any questions about the contents of this letter, please contact Vivek Pinto, PhD at (301) 796-1136 or Vivek.Pinto@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 yours,
/S/

Carlos L. Peña, PhD, MS
Director
OHT 5: Office of Neurological and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health