San Diego Devicemaker Called Out for Late MDR Submissions
The FDA hit device manufacturer Alere San Diego with a Form 483 after finding the company filed multiple medical device reports later than required.
In a Jan. 7-11 inspection of the firm’s San Diego facility , investigators found that the firm filed 39 MDRs beyond the 30-day reporting deadline. The company took years to file some MDRs.
Alere also failed to put in place a corrective or preventive action to ensure that the late MDR reporting wouldn’t happen again.