FDA EIR - Wayne J.G. Hellstrom, M.D. - August 23, 2018

An FDA inspection conducted from August 7-23, 2018, at Wayne J.G. Hellstrom, M.D. in New Orleans, LA, revealed significant deviations in the conduct of clinical investigations. This for-cause inspection primarily focused on two clinical trials, identifying a critical failure by Dr. Hellstrom to personally conduct and supervise the studies. A key violation involved improper delegation of subject eligibility determination, leading to six ineligible subjects being randomized and dosed with investigational products in one study, contravening 21 CFR 312.60.

Further issues included a failure to maintain adequate and accurate case histories and informed consent forms. Specifically, electronic data on floppy disks for subject eligibility often conflicted with printed source documents, with the latter falsely qualifying subjects. Documentation also showed the impossible simultaneous use of study equipment on multiple subjects and instances of non-concurrent completion of source documents, including a backdated informed consent form. Additionally, the site enrolled 28 subjects in a study for which the Institutional Review Board (IRB) had approved only 15.

At the inspection's conclusion, an FDA Form 483, detailing these observations, was issued. Dr. Hellstrom committed to submitting a written response within 15 business days to address the identified deficiencies. Regulatory warnings were also provided.