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.
The FDA hit Laboratorio Reig Jofre for numerous violations at its Barcelona sterile drug manufacturing facility, including inadequate smoke studies and failing to qualify contract service providers. Read More
South Korean OTC drug manufacturer Enprani drew a warning letter from the FDA for CGMP violations observed by FDA investigators at its Incheon facility — including the release of products for sale in the U.S. without checking the identity and strength of their active ingredients. Read More
An FDA inspection of Ajinomoto Althea’s San Diego, California sterile drug facility found serious problems with its equipment setup, including a filling machine conveyor belt that caused vials to fall off the belt. Read More
The FDA issued a warning letter to a Costa Rican OTC drug manufacturer for testing and other violations. and , an inadequate stability program and risks of cross-contamination netted a Costa Rican OTC drug manufacturer a warning letter from the FDA. Read More
A Form 483 issued following an FDA inspection of Novartis subsidiary AveXis’ control testing laboratory — currently the focus of a data manipulation investigation by the agency — is raising concerns about the firm’s own investigation and when it knew about the data discrepancies. Read More
Arguments for inclusion of the nine substances on the list didn’t convince the agency that the products “could not be used, adapted, or diluted rather than compounded from bulk drug substances.” Read More