Tag Archives: Warning Letter

How to Respond to an FDA 483

FDA Inspections & Compliance How to Respond to an FDA 483 — and Prevent a Warning Letter A company that receives a Form 483 has one opportunity to demonstrate control, credibility, and corrective action before the FDA decides whether to escalate. This guide — written by a former FDA field investigator — shows exactly how

FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight

FDA Update PLEASE BE AWARE THAT THE FDA HAS LAUNCHED THE FOLLOWING PROGRAM. WHAT DOES IT MEAN TO YOU? FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight The U.S. Food and Drug Administration today announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources

Import Alerts for Certain Olympus Medical Devices

FDA Update – June 25, 2025 Import Alerts for Certain Olympus Medical Devices Manufactured in Japan – Letter to Health Care Providers We are seeing more and more regulatory actions against foreign companies because of lack of FDA QSR compliance. When a company has a violative inspection, and the FDA does not accept their corrective

BD receives FDA warning letter

FDA Update BD receives FDA warning letter over quality system violations Becton Dickinson (BD) has received a warning letter from the FDA regarding quality system violations at a facility that manufactures its Pyxis medication management system. The FDA identified several concerns, including: Failure to adequately investigate complaints: The FDA found over 92,000 complaints related to

The FDA Sends Two Warning Letters after Inspecting Chinese Syringe Manufacturers

FDA Update The Safety of Syringes Imported into the US Called into Question As: The FDA Sends Two Warning Letters after Inspecting Chinese Syringe Manufacturers The FDA named companies Jiangsu Shenli and Jiangsu Caina as targets of its investigation into the safety of plastic syringes made in China in March. The agency had not completed

FDA Crisis Intervention

FDA Crisis Intervention Though we hope this never occurs, at times companies do run into situations they were not prepared for, or understand, while dealing with the FDA. We have seen this over and over again with our clients worldwide. These unexpected situations could be: A Surprise FDA Inspection Visit When the FDA gets information

FDA Update – FDA Warns Companies Illegally Selling CBD Products

We have been warning clients on the use of CBD and the FDA regulatory requirements. You need to be very careful on the claims you want to make on your products that contain CBDs. Here is some recent FDA actions. The FDA has recently issues 5 warning letters to companies for violating Federal Food, Drug,

FDA Update: FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk.

COVID-19 – FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk This information is not surprising. During the times of consumer and govt panic, there will always be companies trying to take advantage of situation. The FDA tries their best to keep on top of the situation to

An eye-opener on the FDA expectations for importers, distributors and private labelers of dietary supplements!!!

Our analysis of recent FDA warning letters issued to the dietary supplements industry signaled the FDA turned its GMP enforcement emphasis to the importers, distributors and private labelers of dietary supplements. However, time and time again, we see that many of our clients mistakenly believe that manufacturers or contract manufacturers of dietary supplements are the