Warning Letters Fda 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

Main FDA Warning Letter Page. Main FDA Warning Letter Page. Skip to main content; Skip to FDA Search ... CGMP/QSR/Medical Devices/Adulterated : 02/07/2023: 12/27/2022:

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

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

Olympus Medical Systems Corporation - 649726

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

Olympus Medical Systems Corporation MARCS-CMS 649726 — December 12, 2022. Olympus Medical Systems Corporation. Product: Medical Devices. Recipient: …

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 …

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

1 Furthermore, we note that your firm is incorrectly registered with FDA as a manufacturer of Class I medical devices. However, your surgical masks’ medical claims …

Warning Letters Highlight Differences Between …

https://www.fda.gov/cosmetics/warning-letters-related-cosmetics/warning-letters-highlight-differences-between-cosmetics-and-medical-devices

FDA warning letters issued to manufacturers and/or distributors of devices marketed for regrowing hair, weight reduction, spider vein removal, and dermabrasion, as …

Top 10 Reasons for FDA Warning Letters to Medical …

https://www.medtechintelligence.com/feature_article/top-10-reasons-for-fda-warning-letters-to-medical-device-firms/

The following were the Top 10 observations noted in those letters: 21 CFR 803.17 – Failure to develop, maintain, and implement written Medical Device Reporting …

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 …

Violations Found in Medical Device Warning Letters

https://www.natlawreview.com/article/unpacking-averages-violations-found-medical-device-warning-letters

Those procedures can be found in chapter 4 of the FDA’s Regulatory Procedures Manual. Section 4-1-10 of that chapter requires that warning letters include …

FDA Issues Warning Letter to RightEye, LLC For Misbranding …

https://www.lexology.com/library/detail.aspx?g=f981401f-8095-4290-92f7-c3abf8be6890

USA February 13 2023. On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter [1] to RightEye, LLC (RightEye), the …