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Warning Letter Roundup & Recap

Warning Letter Roundup & Recap – Nov. 13, 2018

The manufacturer of VascuLab devices used in vascular pathology was cited for quality systems and Medical Device Reporting violations in the only device-related warning letter released by US FDA this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Nov. 6, 2018

No device-related warning letters were released by US FDA the week of Nov. 6.

Device Warning Letters FDA

Warning Letter Close-Outs – October 2018

US FDA posted online 11 medical device-related close-out letters in October. The letters bear dates going back to June 2018.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Oct. 30, 2018

Four US FDA warning letters addressed to overseas device-makers were posted online by the agency this week, including one to a firm that stored sub-assemblies and final assembled units on the manufacturing floor without proper documentation, and another to a company that sold its catheter tip pressure transducers without FDA pre-market approval.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Oct. 23, 2018

No device-related warning letters were released by US FDA the week of Oct. 23.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Oct. 17, 2018

No device-related warning letters were released by US FDA the week of Oct. 17.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Oct. 9, 2018

Becton Dickinson was using tap water to clean cleanroom surfaces and made other quality systems slip-ups in the only device-related warning letter released by US FDA this week.

Device Warning Letters FDA

Warning Letter Close-Outs – September 2018

US FDA did not release any device-related close-out letters in September.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Oct. 2, 2018

The maker of the Sensation Plus line of intra-aortic balloon catheters was cited for quality systems, misbranding and reporting violations in this week’s only warning letter issued to a medical device company.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Sept. 25, 2018

No device-related warning letters were released by US FDA the week of Sept. 25.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Sept. 18, 2018

The maker of wound-dressing product Omiderm was cited for quality systems violations in the only device-related warning letter released by US FDA this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Sept. 11, 2018

Medtronic is the recipient of two warning letters following unfavorable FDA inspections at its Minnesota and Puerto Rico facilities. The missives were the only device-related letters released by the US agency this week.

Device Warning Letters FDA
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