Fda Medical Device Warning Letters 2022

Warning Letters | FDA - U.S. Food and Drug Administration

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters

Matters described in FDA warning letters may have been subject to subsequent interaction between ...

2022 Safety Communications | FDA

https://www.fda.gov/medical-devices/safety-communications/2022-safety-communications

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical …

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Medical Device Updates CDRH 2022 Annual Report Accomplishments for 2022, including the Pandemic Response, MDUFA V, Device Innovation, over-the-counter (OTC) hearing …

Letters to Industry | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/industry-medical-devices/letters-industry

Untitled Letters 2022 | FDA - U.S. Food and Drug …

https://www.fda.gov/drugs/warning-letters-and-notice-violation-letters-pharmaceutical-companies/untitled-letters-2022

Untitled Letters 2022 | FDA Untitled Letters 2022 These letters are supplied by the CDER Freedom of Information Office and only covers Office of Prescription Drug …

Olympus Medical Systems Corporation - 649726

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/olympus-medical-systems-corporation-649726-12122022

December 12, 2022 Dear Tomohisa Sakurai: During an inspection of your firm located in Hachioji-shi, Tokyo, Japan, on September 6, 2022, through September 9, …

2022 Year in Review: FDA Drug and Device Advertising …

https://www.kslaw.com/news-and-insights/2022-year-in-review-fda-drug-and-device-advertising-and-promotion-enforcement

In 2022, the U.S. Food and Drug Administration (FDA or the Agency) issued a total of nine enforcement letters targeting advertising and promotion violations for …

Wintech Medipro LLC - 640048 - 11/16/2022 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wintech-medipro-llc-640048-11162022

During an inspection of your firm located at 22110 Merchants Way, Suite 170, Katy, Texas, on June 22, 2022 through July 6, 2022, an investigator from the United …

Getsch+Hiller Medizintechnik GmbH - 644680

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/getschhiller-medizintechnik-gmbh-644680-12272022

December 27, 2022 Dear Mr. Hiller: During an inspection of your firm located in Tuttlingen, Nendingen, Germany on July 18, 2022 through July 21, 2022, an …

FDA Issues Warning Letter to RightEye LLC

https://www.natlawreview.com/article/fda-issues-warning-letter-to-righteye-llc-misbranding-and-adulteration

On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter [1] to RightEye, LLC (RightEye), the manufacturer of the …