(Pixabay)
Here is some news of note for the week:
> The FDA has posted information about its now-completed "Data Integrity and Compliance With Drug CGMP" guidance. Q&A
> CDMO Cambrex will invest $1 million at its High Point, North Carolina, site to fit out a 1,300-square-foot analytical laboratory space. Release
> India’s Lupin has downplayed the 22 observations it got in an FDA inspection of its Mandideep cardiovascular “Pril” facility, its cephalosporin API facility and cephalosporin solid oral facility. Release
> India’s Dishman has received a Form 483 in which it got two observations for a plant in Gujarat including one in which it was found to be blending batches that were out of spec for an impurity with batches that met specs. 483
