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Spanish regulators are recommending that EU officials suspend a manufacturing certificate from a Chinese API maker over repeated issues at its plant. Read More
A compounding operation in North Carolina landed an FDA warning letter for compounding drugs without prescriptions and for sterility concerns. Read More
The FDA has faulted two compounders for neglecting to apply quality controls to the production of their sterile drugs, pummeling one of the compounders with 13 citations. Read More
Three clinical investigators were cited for deviating from their investigational plans recently by the FDA for a litany of different reasons. Read More
The FDA is pressing a GlaxoSmithKline subsidiary to make a hard choice about operations at a U.K. plant: either decontaminate the whole facility to address repeated problems with penicillin contamination or else restrict production to penicillin. Read More