# FDA WARNING_LETTER - University of Kentucky - November 21, 2019

Source: https://www.globalkeysolutions.net/records/warning_letter/university-of-kentucky/fe64d235-aa49-472f-82d7-029722b85ebd

> FDA WARNING_LETTER for University of Kentucky on November 21, 2019. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: University of Kentucky
- Inspection Date: 2019-11-21
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On March 26, 2020, the FDA issued a Warning Letter to Dr. Zwischenberger of the University of Kentucky (UK) laboratory following an inspection from November 4-21, 2019. The inspection assessed compliance with regulations for nonclinical laboratory studies, specifically reviewing the "In vivo Evaluation of the Safety and Efficacy of Extracorporeal Circuits for Long-Term Cardiopulmonary Support" study involving the Novalung System device.

The FDA identified serious violations of 21 CFR Part 58 – Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. Key violations include:

1.  **Failure of the Study Director to fulfill regulatory responsibilities (21 CFR 58.33):** The study director did not ensure accurate recording and verification of experimental data, adherence to GLP regulations (e.g., retention of raw data, documentation, specimens per 21 CFR 58.190(a); proper handling of test/control articles per 21 CFR 58.107), transfer of data/specimens to archives, or adherence to the protocol. Examples included missing/incorrect device RGA forms, unsecured storage of records/data, and unamended protocol changes regarding device kits used for sheep.

2.  **Failure of the Quality Assurance Unit (QAU) to fulfill its responsibilities (21 CFR 58.35

## Related Officers

- [Division Director](https://www.globalkeysolutions.net/people/soma-kalb/dc303fda-2408-43d5-9790-079ec1edcb29)

Company: https://www.globalkeysolutions.net/companies/university-of-kentucky/e6be65a8-8c17-4378-934a-620b8eed5c2e

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