FDA Warning Letter Recap
The US FDA issued four close-out letters last month. Three resolved warning letters that had been issued to duodenoscope manufacturers about problems with Sec. 522 postmarket studies.
A maker of skin-care products was cited for premarket violations in the only device-related warning letter released by the US agency last month.
A handful of domestic and foreign manufacturers were dinged by the US FDA for problems with quality systems. The agency released five device-related warning letters last month.
The US Food and Drug Administration posted one device-related closeout letter in March, which went to hemodialysis product company Diasol.
The US Food and Drug Administration issued two close-out letters in February, with missives going to Invisi Smart Technologies and Indus Medicare.
No device-related warning letters were released by the US FDA last month.
US FDA data shared with Medtech Insight show that the number of quality-related warning letters sent to device manufacturers in calendar year 2021 ticked up 33% from 2020. Last year’s enforcement missives were also the most handed out by the agency in four years.
The US FDA released only one device-related close-out letter so far this year.
The US agency released only one device-related warning letter last month.
The US FDA released only one device-related close-out letter last month.
Quality systems and Medical Device Reporting violations were noted by US FDA investigators during an on-site inspection of Medtronic’s Northridge, CA, facility. A total of seven device-related warning letters were released by the agency last month.
The US FDA issued three device-related close-out letters in November, with missives going to marketers of power wheelchairs, face masks, and mask decontamination systems.
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