The United States and the European Union (EU) amended the 1998 U.S.-EU Mutual Recognition Agreement for Pharmaceutical Inspections. The US and the EU will now be able to use each other’s inspections of pharmaceutical... READ MORE
On February 27, 2017, an US Food and Drug Administration (USFDA) Warning Letter was issued to the two owners of DeGrave Dairy. This Warning Letter was issued for violations of the Federal Food,... READ MORE
On March 2, 2017, an US Food and Drug Administration (USFDA) Warning Letter was issued to seafood importers, Lucky Pacific Corp and Kamli International Co. Ltd. This Warning Letter was issued for serious... READ MORE
On February 14, 2017, an US Food and Drug Administration (USFDA) Warning Letter was issued to Hospira. This Warning Letter was issued for significant violations of current good manufacturing practice (CGMP) regulations for... READ MORE
Negative inspection findings on an FDA-483, or regulatory actions like warning letters, debarment, consent decrees, seizures and injunctions can have a serious impact on your FDA regulated company. Therefore, it’s critical to stay up to date and in compliance with FDA laws, regulations, and guidelines.
The US Food and Drug Administration (FDA) inspects facilities to confirm their compliance with agency regulations to protect the health of the public. FDA Inspections are performed on everything from pharmaceuticals and cosmetics to medical devices and food, to assure the product’s quality and safety.