Hologic GMP violations cited in Nov. 21 warning letter hold up Sahara PMA approval.
This article was originally published in The Gray Sheet
Executive Summary
HOLOGIC SAHARA PMA APPROVAL HELD UP BY GMP DEFICIENCIES cited by FDA in a Nov. 21 warning letter, the firm says. The brief list of good manufacturing practices violations identified by the agency in the warning letter appear to be minor violations that likely will not pose a lengthy delay for the firm in its pursuit of FDA premarket approval for the ultrasound bone densitometry system.