# FDA WARNING_LETTER - Philosys Co. Ltd - August 30, 2018

Source: https://www.keypedia.com/records/warning_letter/philosys-co-ltd/d6b23bd1-fc51-43f4-b194-eadbc4b473ba

> FDA WARNING_LETTER for Philosys Co. Ltd on August 30, 2018. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Philosys Co. Ltd
- Inspection Date: 2018-08-30
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On January 14, 2020, the FDA issued a Warning Letter to Mr. In Hwan Choi, regarding an inspection of his firm in Gunsan-si, Korea, from August 27-30, 2018. The firm manufactures Self-Monitoring Blood Glucose (SMBG) test systems, which are medical devices. The inspection revealed these devices are misbranded under 21 U.S.C. § 352(t)(2) due to failures in Medical Device Reporting (MDR) as required by 21 U.S.C. § 360i and 21 CFR Part 803.

Key violations include:
1. **Failure to submit timely MDRs:** The firm failed to report a serious injury (hypoglycemia due to false high glucose readings from a Gmate VOICE system) within 30 days, as required by 21 CFR 803.50(a)(1). A draft MDR (K113636-2015-00001) was noted, but FDA had not received it. The firm's response was inadequate, lacking evidence of systemic corrective actions, including a retrospective review of adverse events. An English translation of the corresponding complaint file (CS15-0420-01) was also requested.
2. **Failure to maintain MDR decision-

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## Related Officers

- [Director](https://www.keypedia.com/people/timothy-t-stenzel/c53bdcbc-5f38-4c82-b8fc-181624201c10)

Company: https://www.keypedia.com/companies/philosys-co-ltd/c643e67d-d3d0-4524-ae64-b40a377974a2

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