Fda Warning Letters Medical Devices

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

Learn about the types of warning letters on FDA's website. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA …

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

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

2021 Letters to Health Care Providers | FDA

https://www.fda.gov/medical-devices/letters-health-care-providers/2021-letters-health-care-providers

04/09/2021. Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers. 04/01/2021. Potential for False Results with Roche Molecular …

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

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

FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes CDRH recently issued two warning letters to a leading manufacturer of endoscopes, Olympus Medical …

FDA Issues Two Warning Letters to Leading …

https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-issues-two-warning-letters-leading-manufacturer-endoscopes

The FDA’s Center for Devices and Radiological Health (CDRH) recently issued two warning letters to a leading manufacturer of endoscopes, Olympus Medical …

Letters to Health Care Providers | FDA

https://www.fda.gov/medical-devices/medical-device-safety/letters-health-care-providers

Medical Devices Medical Device Safety Letters to Health Care Providers Letters to Health Care Providers The most recent letters to health care providers are listed by year …

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

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

Letters to Industry. This webpage is a resource for external stakeholders that contain correspondence issued by the Center for Devices and Radiological Health (CDRH) for a …

Olympus Medical Systems Corporation - 649726

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

Under section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321 (h), these products are devices because they are intended for use in the …

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 …

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

November 16, 2022. Dear Mr. Wang: During an inspection of your firm located at 22110 Merchants Way, Suite 170, Katy, Texas, on June 22, 2022 through July …