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# ‘Objectionable Conditions’ at University of Kentucky Lab
- URL: https://www.fdaweb.com/objectionable-conditions-at-university-of-kentucky-lab/
- Published: 2020-05-07T12:00:00.000Z
- Updated: 2026-09-14T16:14:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146747

An 11/4-11/21/19 FDA inspection at the University of Kentucky laboratory conducted by the FDA Office of Bioresearch and Monitoring Operations found that activities and procedures related to the laboratory’s participation in nonclinical laboratory studies of the Novalung System did not comply with applicable regulations. A just-released 3/26 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/university-kentucky-600258-03262020?ref=fdaweb.com) says the specific violations of good laboratory practice for nonclinical laboratory studies were: 

- failure of the study director to fulfill regulatory responsibilities; and
- failure of the quality assurance unit to fulfill its responsibilities.

FDA recommends that the laboratory conduct a systemic audit of its nonclinical lab procedures to ensure that it has adequately captured and resolved its deviations. The lab was told to respond with documentation of corrective and preventive actions it has taken or will take to correct the violations and prevent their recurrence, with projection completion dates for each action.