Ion Labs Gets Warning After Repeated cGMP Violations
The agency conducted an inspection of the Clearwater, Fla., facility from Nov. 24 to Dec. 31, 2008, according to the warning letter dated July 31 and posted recently on the FDA’s website. The agency acknowledged receiving the company’s Feb. 9 responses to the Form 483 observations but called those responses inadequate.
The company also failed to correct previous violations, including the failure to establish test procedures and laboratory control mechanisms designed
to ensure drug purity, strength and quality of products, according to the letter.
Drug GMP Report