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.
Tower Laboratories, a contract manufacturer of OTC drugs, has received an FDA Form 483 for failure to fully investigate potential metal contamination of raw materials and finished products. Upon confirming metal contamination in six drums of aspirin raw material, the quality control unit at Tower’s Montague, Mich., manufacturing facility continued to use the tainted material in the blending process — but not during the compression process — until all drums were depleted, the form states. No “material complaint” was issued on the contamination per company protocol. Drug GMP Report