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A large Texas compounder has rejected the FDA’s formal request to recall all of its sterile products after an inspection found 22 contaminated lots, a stance that means the dispute could move to court. Read More
More than a year after being warned by the FDA for poor quality, Alexion Pharmaceuticals received a fresh Form 483 for problems surrounding gowning procedures and other quality issues. Read More
Manufacturers operating in Europe should report any product-quality defect to the drug application holders and individual EU regulatory bodies if the incident requires a recall or creates supply restrictions, according to a revised chapter of a European Commission guideline on GMPs. Read More
Compounding pharmacies are asking the FDA to overhaul its guidance for interim good manufacturing practices, contending the recommendations for such things as the cleanliness of air filters and presence of particulates are unclear and subjective. Read More
FDA officials sought to clarify how the agency’s authority to punish drugmakers for obstructing facility inspections applies to such issues as divulging trade secrets, accessing emails and translating documents into English. Read More
The FDA is honing in on roughly eight to 10 quality metrics that the agency plans to collect from drugmakers starting in 2015, and expects to publish a guidance that names them by the end of the year. Read More
Within two years, the FDA will begin assigning all facility inspections to specialized teams that have detailed expertise in the lifecycle of the particular drug that is subject to inspection. Read More
FDA investigators and their European counterparts are comparing training and auditing procedures as the first steps in a new push to increase mutual reliance on each other’s inspections. Read More
Manufacturers of moderate-risk devices with a good record of GMP compliance could see less of government inspectors, under proposed amendments to South Korea’s good manufacturing practice regulations. Read More