- Taewoong 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 Avenue|
White Oak Building 66
Silver Spring, MD 20993
NOV 25, 2014
VIA UNITED PARCEL SERVICE
Taewoong Medical Co., Ltd.
14 Gojeong-ro, Wolgot-Myeon
Republic of Korea
Dear Mr. Shin:
During an inspection of your firm located in Gyeonggi-Do, Republic of Korea, on July 28, 2014, through July 31, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Taewoong Niti-S Biliary and Esophageal stents. 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 your Niti-S Biliary and Esophageal stent 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 (MDR).
We received a response from you dated August 14, 2014, 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. Your firm’s response from Mr. Sang-Hyung Park dated October 31, 2014, to the FDA 483 was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. The October 31, 2014 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:
Failure to submit a report to the FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury, as required by 21 CFR Part 803.50(a)(1). For example, two complaints reference MDR reportable events where your firm did not submit an MDR report to the FDA within 30 calendar days. Specifically:
- Complaint #1032R140314 refers to an esophageal stent that was implanted in the middle and lower esophagus in November 2013 due to esophageal cancer. The patient received a second stent due to tumor overgrowth. The patient’s condition deteriorated rapidly and the patient was taken to the hospital where a computerized tomography (CT) scan confirmed an aortic fistula. The patient died from aortic perforation. Your firm failed to submit a death report to the FDA for this event.
- Complaint #882R130816 refers to a patient in the hospital with an intestinal occlusion. A CT scan confirmed that a biliary stent fractured (2 cm) at the intestine ileum with stool. The remaining stent fragment was surgically removed. This information reasonably suggests that the device may have caused or contributed to a reportable serious injury (intestinal occlusion) requiring medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. Your firm failed to submit a serious injury report for this event.
The adequacy of your firm’s response cannot be determined at this time. Your firm submitted CAPA CAR-A14-003, dated 2014-08-05, which states that corrections to address the above issues will be completed by August 31, 2014. However, we have not received evidence of implementation of the actions listed in the referenced CAPA. In addition, your firm provided a copy of its revised MDR procedure titled “Quality Procedure (b)(4).” However, the procedure is written in Korean. Please provide an English version of the procedure.
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
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 procedures that ensure that any complaint involving the possible failure of a device, labeling, or packaging meets any of its specifications be reviewed, evaluated and investigated unless such investigation has already been performed for a singular complaint, and another investigation is not necessary, as required by 21 CFR 820.198(c). For example, your firm failed to adequately evaluate and investigate Customer Complaints 1121R140623 and 1078R140515, involving reported delivery system failure of Niti-S Biliary and Esophageal TTS stents during surgery.
The adequacy of your firm’s response cannot be determined at this time. Your firm stated it has issued a CAPA Request (CAR-A14-003) to the Quality Management department. However, we have not received evidence of implementation of the corrective actions listed in the referenced CAPA.
2. Failure to establish and maintain procedures that ensure that where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a). For example, your firm failed to adequately validate (b)(4) used in the manufacturing of various devices, including the Esophageal TTS stent. According to our investigator, your firm conducts 100% visual inspection, and has a sampling method to evaluate (b)(4) activities after sterilization. However, your firm agreed with the investigator that the identified processes were not adequately validated.
The adequacy of your firm’s response cannot be determined at this time. Your firm stated it has reviewed its validation reports, including its packaging process, which includes the blister and pouch sealing process, as well as the UV bonding process. Your firm concluded that the validations were not performed adequately, and stated it will establish and perform the revalidation with a new protocol. Your firm stated it will retrain its employees on the revised procedure and monitor the process periodically.
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 #442438 when replying. 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
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