In a recently posted FDA Warning Letter to a registered outsourcing facility the FDA cited the registration and reporting requirements of 503B(b) the requirement to submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations)”
I believe this is the first warning letter to an outsourcing facility that has referenced or cited adverse event reporting. The FDA cited three areas where the Firm’s SOP was inadequate. The examples cited included:
1. The SOP does not adequately define a serious adverse event consistent with the definition of serious adverse drug experience in 21 CFR 310.305(b);
2. The SOP does not include information regarding submitting a follow-up report of an adverse event to FDA; and,
3. The SOP makes no reference to the adverse event submission process utilizing the Safety Reporting Portal (SRP) or Electronic Submission Gateway (ESG) required under 21 CFR 310.305(e).
Outsourcing facilities should review their adverse event reporting SOP to ensure that it complies with the reporting requirements of 503B(b)