Delsam Pharma LLC – FDA EIR, Mar 24, 2023

An FDA inspection of Xttrium Laboratories, Inc. in Mount Prospect, IL, was conducted from May 6-25, 2016. This was a routine surveillance inspection focused on post-marketing adverse drug experience (PADE) reporting, carried out under Compliance Program 7353.001. While no formal FDA-483 observations were issued, the agency communicated three significant concerns. Firstly, the company lacked written procedures for the electronic submission of Individual Case Safety Reports (ICSRs), including 15-day Alert Reports, a mandatory requirement under 21 CFR 314.80 for post-marketing adverse drug experience reporting. The firm acknowledged being unaware of this regulation and had not been submitting these reports electronically since 2014. Secondly, their procedures for triaging and collecting ADE information from various sources, such as company websites and personnel like sales representatives, were deemed inadequate. Lastly, the complaint handling procedure did not instruct sales representatives to maintain a log or diary of complaints and ADE information they received in the field. Xttrium Laboratories committed to addressing these issues. They pledged to update their procedures to ensure electronic submission of ICSRs, revise awareness training and written protocols to enhance ADE information collection from all potential sources, and amend the complaint handling procedure to include proper record-keeping instructions for sales representatives.