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Warning Letter Roundup & Recap

Warning Letter Roundup & Recap – July 17, 2018

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – July 10, 2018

No device-related warning letters were released by US FDA the week of July 10.

Device Warning Letters FDA

Warning Letter Roundup & Recap – July 3, 2018

No device-related warning letters were released by US FDA the week of July 3.

Device Warning Letters FDA

Warning Letter Close-Outs – June 2018

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – June 26, 2018

No device-related warning letters were released by US FDA the week of June 26.

Device Warning Letters FDA

Warning Letter Roundup & Recap – June 19, 2018

No device-related warning letters were released by US FDA the week of June 12.

Device Warning Letters FDA

Warning Letter Roundup & Recap – June 12, 2018

US FDA did not release any device-related warning letters the week of June 12.
Device Warning Letters FDA

Warning Letter Roundup & Recap – June 5, 2018

US FDA did not release any device-related warning letters the week of June 5.

Device Warning Letters FDA

Warning Letter Close-Outs – May 2018

US FDA released one device-related close-out letter in May.

Device Warning Letters Enforcement

Warning Letter Roundup & Recap – May 29, 2018

US FDA did not release any device-related warning letters the week of May 29.

Device Warning Letters FDA

Warning Letter Roundup & Recap – May 22, 2018

US FDA did not release any device-related warning letters the week of May 22.

Device Warning Letters FDA

Warning Letter Roundup & Recap – May 17, 2018

German maker of the Twion Power Push-Rim Power Drive System cited for quality systems violations; RADLogics was marketing its AlphaPoint software without pre-market approval or clearance from US FDA.

Device Warning Letters FDA
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