Belcher Pharmaceuticals, LLC – FDA EIR, May 24, 2019

An FDA inspection of Belcher Pharmaceuticals, LLC in Largo, FL, was conducted from May 20-24, 2019. The inspection specifically focused on the firm's Postmarketing Adverse Drug Experience (PADE) reporting systems, operating under Compliance Program 7353.001. While no FDA Form 483 (Inspectional Observations) was issued, several areas for enhancement were identified through discussion. These included deficiencies in Standard Operating Procedures (SOPs) regarding scientific literature review, inconsistent time periods in a Cephalexin PADER, and the absence of unique identification numbers or adverse event summaries in certain reports. The company also had instances of late submission for one 15-day adverse drug event report and two annual reports. Furthermore, SOPs contained outdated references to paper submissions instead of the current electronic-only requirement, and complaint record retention policies did not align with the 10-year mandate for human drug adverse events. Belcher Pharmaceuticals promptly updated relevant SOPs during the inspection to address electronic submission and record retention requirements. Management acknowledged the other identified issues and committed to implementing process improvements to ensure complete and timely PADE reporting in the future.