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Lax procedural documentation in quality control units topped the list of reasons why drugmakers received Form 483s in fiscal 2014, its ninth consecutive year at the top, while poor laboratory controls jumped to second place from fourth in the annual rankings of inspection observations. Read More
The FDA is considering employing unmanned aerial drones to aid in facility inspections, although it’s unclear whether that would encompass drug manufacturing plants. Read More
A compounding pharmacy pled guilty to manufacturing contaminated products that caused skin infections, the first compounder to be convicted of criminal charges for poor quality since the FDA gained new authority in 2013. Read More
Drugmakers and active pharmaceutical ingredient manufacturers in Europe that produce multiple products in one facility should justify exposure to contaminants and follow specific steps to clean equipment and reduce risks of cross-contamination, according to a new EU guideline. Read More
Reversing course, the UK’s healthcare cost agency now is recommending Janssen’s Stelara for psoriatic arthritis after the drugmaker agreed to provide the drug at a discount. Read More
The FDA plans to consolidate its 16 districts overseeing pharmaceuticals imports into either four or five districts under a reorganization plan that aims to make inspection policies and procedures more uniform regardless of port of entry. Read More
Lax procedural documentation in quality control units topped the list of reasons why drugmakers received Form 483s in fiscal 2014, its ninth consecutive year at the top, while poor laboratory controls jumped to second place from fourth in the annual rankings of inspection observations. Read More
A compounding pharmacy pled guilty last week to manufacturing contaminated products that caused skin infections, the first compounder to be convicted of criminal charges for poor quality since the FDA gained new authority in 2013. Read More
Drugmakers may soon have to report to the FDA how they decide when to launch a CAPA investigation, if they have a performance index for their product’s critical quality attributes and the seniority level of the employee who signs off on the annual product review. Read More
King Pharmaceuticals received a Form 483 after agency investigators discovered problems with damaged equipment and cleanroom suits filled with holes. Read More