Richard N Greenberg MD – FDA EIR, Apr 2, 2015

An FDA inspection of Richard N Greenberg MD in Lexington, KY, took place from March 30 to April 2, 2015. The clinical research site was found to be largely compliant with FDA regulations, as evidenced by the absence of an FDA Form 483 detailing objectionable conditions. The main issue identified was a record-keeping concern regarding the storage of investigational products. Specifically, monthly temperature logs for the pharmacy's refrigerator and freezer lacked distinct identification, which made it difficult to definitively confirm that the test article maintained consistent temperature control within the same specific device throughout the study.

In response to this finding, the unblinded pharmacist verbally confirmed that only one refrigerator and one freezer in the Investigational Drug Service (IDS) room were used for the study during the relevant period, providing property identification numbers. Dr. Greenberg committed to addressing this by discussing proper record-keeping practices with the pharmacy staff to prevent similar issues in the future. The inspection concluded without further actions or questions, indicating satisfactory resolution of the discussed item, and no other significant protocol deviations were observed.