# FDA WARNING_LETTER - Sooil Development Co., Ltd. - January 23, 2020

Source: https://www.keypedia.com/records/warning_letter/sooil-development-co-ltd/c53e2407-e3de-4044-a1a2-09e2bca43dc2

> FDA WARNING_LETTER for Sooil Development Co., Ltd. on January 23, 2020. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sooil Development Co., Ltd.
- Inspection Date: 2020-01-23
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On April 16, 2020, the FDA issued a Warning Letter to SOOIL Development Co., Ltd. following an inspection from January 20-23, 2020, at their Gyeonggi-do, Republic of Korea facility, which manufactures the DANA Diabecare IIs insulin pump. The inspection found the devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting).

Key violations include:
1.  **CAPA (21 CFR 820.100(b)):** Inadequate documentation of corrective and preventive actions, specifically regarding root cause investigation for a missing code in traceability.
2.  **Environmental Control (21 CFR 820.70(c)):** Failure to establish adequate procedures for controlling environmental conditions, such as radiated electromagnetic fields during manufacturing.
3.  **Calibration (21 CFR 820.72(b)):** Inadequate calibration procedures, lacking requirements for retrospective review or

## Related Documents

- [483 - 2020-01-23](https://www.keypedia.com/records/483/sooil-development-co-ltd/53948ae5-cc26-4d71-ad4d-a5780da5abd1)

## Related Officers

- [Jong Hyun Kim](https://www.keypedia.com/people/jong-hyun-kim/0fe09338-3686-4454-95c5-82d5d23a3a93)
- [Director](https://www.keypedia.com/people/timothy-t-stenzel/c53bdcbc-5f38-4c82-b8fc-181624201c10)

Company: https://www.keypedia.com/companies/sooil-development-co-ltd/143e4065-e074-4301-b860-2b20304c5678

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7