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Novel Laboratories failed to adequately address black specks on drug products and pieces of rubber found in a product container, according to a Form 483 given to the drugmaker. Read More
Roche subsidiary Genentech received a Form 483 from the FDA after an inspection found parts of the processing area for making active pharmaceutical ingredients (APIs) was covered with what resembled rust. Read More
China’s Food and Drug Administration (CFDA) is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More
Nevada-based Green Valley Drugs, which recalled all of its sterile compounded products in April, has been warned by the FDA for a lack of sterility assurance and general quality control. Read More
Alimera Sciences’ negotiations with the FDA on Iluvien have put the diabetic macular edema drug on a glide path to potential approval — a startling about-face following three complete response letters (CRL) for the drug’s application. Read More
The FDA and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications. Read More
In a new enforcement initiative intended to boost drugmaker quality, the European Medicines Agency (EMA) has begun publishing the names of manufacturing facilities that fall out of compliance with good manufacturing practices (GMP). Read More
The European Medicines Agency has concluded a review of lax adverse event reporting at Roche, concluding the company’s failure last year to report adverse events for 19 drugs did not cause any additional risks to consumers. Read More
OTC drugmaker AmeriDerm Laboratories has a long history of failing to test its Paterson, N.J., plant’s water supply for objectionable microorganisms, the FDA says. Read More