The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Three U.S. drug manufacturers were hit with warning letters over shortcomings encountered at their facilities, including data integrity concerns, improper equipment calibration and unproven water systems. Read More
The FDA hit Puerto Rico drugmaker Caribe Holdings with a Form 483 for not cleaning equipment and utensils at suitable intervals to prevent product contamination and for long delays in validating cleaning procedures. Read More
Over-the-counter drug manufacturer Church and Dwight was hit with a Form 483 for violations at its Lakewood, New Jersey facility, including incomplete laboratory records and shortcomings in its microbiological testing. Read More