FDA WARNING_LETTER - University of Kentucky - November 21, 2019

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