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The FDA issued a 483 to Glades Drugs after an inspection revealed that three adverse event reports were associated with Vitamin D3 supplement capsules. Read More
Two U.S. API makers are taking heat for a host of recordkeeping failures and related issues following FDA inspections of their production facilities. Read More
Earlier this summer the FDA recommended a five-point scale to measure topical patch adhesion for drugmakers submitting abbreviated new drug applications (ANDA). However, the recommendations have only raised more questions. 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 restrict production to penicillin. Read More