Medical Device Warning Letters

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

Posted Date Letter Issue Date Company Name Issuing Office Subject Response Letter Closeout Letter Excerpt; 02/07/2023: 12/21/2022: Salon Technologies International, Inc.

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

WARNING LETTER. Olympus Medical ... 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. We received a response from your firm, dated …

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 warning letters concern violations related to medical device reporting (MDR) requirements and quality system regulations for endoscopes and endoscope …

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 …

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 …

Common Reasons Companies Receive Warning Letters …

https://www.mastercontrol.com/gxp-lifeline/prelude-to-an-fda-warning-letter/

Medical Device Warning Letters. Anyone in medical device manufacturing knows that compliance is a colossal and complex effort. Any number of things can slip through the cracks and fall right into the lap of a …

FDA posts trio of medical device warning letters

https://www.medtechdive.com/news/fda-posts-trio-of-medical-device-warning-letters/573194/

The number of medical device warning letters issued annually fell almost 90% from 2015 to 2019. With a reorganization the Center for Devices and Radiological …

Device warning letters plunged nearly 90% over 5 years.

https://www.medtechdive.com/news/device-warning-letters-plunged-nearly-90-over-5-years-an-fda-official-pre/570175/

FDA's device center issued just nine warning letters in the most recent fiscal year, down from 81 in 2015. But with a major reorganization complete, regulators say they …

Warning Letters 10/4/2020: Medical Device Adverse Events

https://redica.com/pharma-devices-fda-warning-letters-10-4-2020/

LEC Custom Products, Inc. LEC Custom Products, Inc (Brampton, Ontario) received a Warning Letter on September 24, 2020, based on the outcome of an inspection ending March 6, 2020. The firm …