- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Medical Devices
Recipient NameMs. Yun Hee Yeom, PhD
- Sooil Development Co., Ltd.
62, Yonggu-daero 2325 beon-gil
- Issuing Office:
- Center for Devices and Radiological Health
April 16, 2020
Dear Ms. Yeom:
During an inspection of your firm located in Gyeonggi-do, Republic of Korea on January 20, 2020 through January 23, 2020, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the DANA Diabecare IIs insulin pump. 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 adequately document corrective and preventive action activities and/or results, as required by 21 CFR 820.100(b).
For example: the root cause for a missing code in your firm’s traceability procedure was not adequately investigated in CAPA-190903-05, as it did not document that your firm’s Design Controls process was not followed.
2. Failure to adequately establish procedures to control environmental conditions, as required by 21 CFR 820.70(c)
For example: your firm’s environmental controls checklist and process (document number QF-706-09, rev.9_190911) does not include any controls systems, procedures, equipment, or test methods to control for or mitigate the effects of radiated electromagnetic fields or other types of electrical leakage present in the environment, such as that from (b)(4) used during manufacturing of electrical components.
3. Failure to adequately establish calibration procedures, as required by 21 CFR 820.72(b).
For example: in your firm’s procedures for measurement device control (document number QF-401-01 rev.8), the sections pertaining to equipment repairs and calibration (translation of section 5.7 of document number QF-401-01 rev.8) do not contain requirements for retrospective review or evaluation or analysis of potentially affected product in situations where measuring equipment has been found to be outside the limits of acceptable calibration. There are no provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device's quality when accuracy and precision limits are not met, are required by the regulation.
4. Failure to adequately establish procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 CFR 820.50.
For example: your firm’s supplier performance monitoring procedures (document number QF-705-04 rev 8_190802) did not typically apply to contractors and consultants who provide services. When your firm was questioned by the investigator about how they assess and ensure the annual performance of a service provider or consultant who does not supply products, your firm responded that your firm’s supplier performance score sheet not been set up for this type situation. The regulation requires that your firm establish procedures or processes to ensure that the performance of service providers meet your firm’s requirements.
5. Failure to adequately establish procedures for training and identifying training needs, as required by 21 CFR 820.25(b).
For example: on January 23, 2020 two technicians were observed not wearing electrostatic discharge (ESD) wrist straps properly. Improper use of the ESD wrist straps demonstrated that the training provided by your firm (documented on form QF-601-02 rev. 5) was inadequate or may have lost its effectiveness over time and that all employees were not trained to adequately perform their assigned responsibilities as required by the 21 CFR 820.25(b).
6. Failure to adequately establish procedures for quality audits, as required by 21 CFR 820.22.
For example: your firm’s 2019 audit plan and audit checklist do not correlate the audited areas to their respective FDA quality system regulation requirement as a means of assessing if your firm’s quality system was compliant with FDA regulations as required by your firm’s quality manual (document number QF-802-01 rev.6).
7. Failure to adequately establish procedures for management review, as required by 21 CFR 820.20(c).
For example: your firm’s management review dated February 19, 2019 does not document the attendee’s signatures as proof they attended as required by the firm’s management review procedures. Also, the management review agenda did not include an item regarding “(b)(4)” as required by your firm’s management review procedures (document number QF-401-01 rev.8).
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:
Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
For example: during the inspection your firm provided the investigator with a document identified as your firm’s MDR procedure, titled “Quality Procedure”, SQP-502, Rev.16, dated 2019-12-28. Please note that the procedure is written in a foreign language. As such, FDA cannot make a full assessment of your firm’s MDR procedure. In addition, although your firm provided an English translation of Section 7 (adverse event reporting procedures) of SQP-502, it does not contain information that would indicate that it was an MDR procedure created in accordance with the requirements in 21 CFR 803.17.
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(s) 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 Regulatory Programs, Division of Regulatory Programs 2, FDA Inspections and Regulatory Audits Team, White Oak Building 66, Rm 3540, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #607127 when replying. If you have any questions about the contents of this letter, please contact: Joshua Balsam at 240-402-6521 or firstname.lastname@example.org.
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.
Timothy T. Stenzel, M.D., Ph.D.
OHT7: Office of In Vitro Diagnostics
and Radiological Health
Office of Produce Evaluation and Quality
Center for Devices and Radiological Health
Jong Hyun Kim
9919 Hibert Street
San Diego, CA US 92131