News of Note—FDA gets specific on data integrity rules; Lupin, Dishman tagged with 483s


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

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> 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

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