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The FDA has issued Form 483 inspection reports to seven drug companies for a variety of GMP and other lapses, including problems with data integrity, complaint handling and visual examinations of finished drug products. Read More
Healthcare regulators have set their sights on type 2 diabetes drug metformin to see if it contains unsafe amounts of N-nitrosodimethylamine (NDMA). Read More
Four U.S. drugmakers drew FDA warning letters for violations ranging from the use of contaminated water to the promotion of unapproved drug products. Read More
Ranitidine can generate N-nitrosodimethylamine (NDMA) when stored at higher temperatures, a research laboratory has found, raising new safety concerns. Read More
The FDA’s warning letters for 2019 once again targeted many familiar GMP failures, such as quality units that either lacked or failed to follow written procedures. Read More
A drugmaker in the Czech Republic was listed on the EudraGMDP inspection database for serious deficiencies at its Prague facility including the presence of mold and dead insects. Read More
The FDA outlined its current thinking on the information sponsors of transdermal and topical delivery systems (TDS) should include in their NDAs and ANDAs in a draft guidance. Read More
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) released draft advice for GMP inspectors on evaluating risk-based changes to pharmaceutical quality systems (PQSs). Read More