We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. Read More
Ensuring data integrity is a crucial task for drug manufacturers wishing to stay out of trouble with the FDA, a top enforcement official at the agency told an industry conference. Read More
The FDA issued a warning letter to a Texas drug compounding facility after it failed to resolve problems identified during an inspection, including serious deficiencies in sterile drug processing. Read More
ORA and CDER officials provided an update on the agency’s Concept of Operations initiative in a Thursday panel discussion at the FDLI’s Enforcement Litigation and Compliance Conference in Washington D.C., detailing the next steps in implementing the concept. Read More
The FDA’s chief counsel said the agency is examining the legal circumstances where a company’s senior personnel and management could be held not only civilly responsible, but also criminally responsible for the actions of those working under them. Read More
Between 2015 and 2016, the number of GMP inspections conducted by European Economic Area authorities of non-EU sites dropped by nearly 25 percent, but the authorities reported more findings of non-compliance over the same time period. Read More
The FDA warned a Korean manufacturer over significant GMP violations observed during an inspection in March, including its failure to test incoming components. Read More
The FDA flagged Horizon Pharmaceuticals for failure to follow sanitation procedures, insufficient investigations into customer complaints and inadequate reviews of product discrepancies, among other issues. Read More