FDA 483 - Belmora LLC - September 13, 2017

Belmora LLC, a labeler/distributor in Arlington, VA, was inspected by the FDA from August to September 2017. The inspection revealed significant deficiencies in post-marketing surveillance, specifically regarding the lack of written procedures for adverse drug experience reporting and the failure to submit required periodic and annual reports for its approved drug product, Lidocaine. These findings indicate a lack of compliance with regulatory requirements for drug product oversight.