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 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 Inspections: How to Respond to a Request for an Affidavit By Alan P. Schwartz, Senior Partner, mdi Consultants Dealing with the FDA during an inspection could cause real emotional stress to say the least. Should you respect the request of FDA investigator if you are not sure what the consequences would be at a
FDA Update February 10, 2022 Warning – FDA could be knocking on your door! The FDA Restarts Routine Domestic Surveillance Inspections With the decline of Covid-19 cases across the country, the FDA has decided to re-start their routine domestic surveillance inspections in the US. The FDA will also resume their foreign surveillance inspections provided that
FDA Update – July 13, 2020 COVID-19 Update – FDA prepares for resumption of domestic inspections with new risk assessment system As a follow up to the update of July 10 on this item we have broken out some of the more critical areas on the FDA On-Sight Inspectional restart. The FDA is working towards
BEWARE – FDA Inspections in China with 5 day notice mdi recently received an email from one of our clients in China that read: “We just received a “notice” from the USA FDA via the US Embassy in Beijing that there will be an inspection this coming Monday. Is this normal to be contacted from
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