Fda Warning Letters Medical

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 and the letter recipient...

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

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

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

https://cacmap.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 FDA and the letter recipient that may have changed the …

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

FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes Violations include failure to adhere to medical device reporting requirements and quality …

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 …

USA Medical LLC - 631500 - 08/03/2022 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usa-medical-llc-631500-08032022

During the inspection, FDA investigators determined that your firm is a medical device manufacturer and distributor of SARS-CoV-2 Antigen Rapid Test kits distributed under …

FDA Warning Letter & Inspection Observation Trends …

https://www.thefdagroup.com/blog/2019-fda-warning-letter-inspection-observation-trends

The majority of pharmaceutical warning letters were issued to US companies. Over half (46 to be exact) of the 81 warning letters were issued to companies located in the United States. A detailed list of each …

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 …