FDA 483 - Allstar Marketing Group Llc - March 21, 2022

Allstar Marketing Group Llc, a medical device manufacturer in Hawthorne, NY, was inspected by the FDA. The inspection revealed a significant compliance issue regarding the firm's failure to develop written Medical Device Reporting (MDR) procedures. Specifically, the company lacked electronic MDR procedures and had not established an Electronic Submissions Gateway (ESG) account to handle serious injury and death incidents.