FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

San Diego Devicemaker Called Out for Late MDR Submissions

May 3, 2019
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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.

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