FDA Issues First Warning Letter Addressing AI-Generated Drug Specifications and Master Production Records FDA issues a Warning Letter addressing “the use of AI in creating the drug product specifications, procedures, and master production or control records” The FDA recently issued a warning letter to a US pharma company that had many FDA cGMP issues. This is the first time we have seen
The FDA themselves state it is industry’s responsibility to work with investigators before they leave the company to remove all incorrect points on the 483. The FDA is also supposed to annotate the 483 concerning your corrective actions that were accomplished during the inspection. From latest experience with the new FDA investigators, this advice doesn’t
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
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
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
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 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
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,
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
mdi Consultants, Inc