Ion Labs Gets Warning After Repeated cGMP Violations

November 13, 2009
The FDA warned Ion Labs in a letter about violations of cGMPs that include the failure to establish test procedures or other laboratory control mechanisms to ensure drug purity and to put in place written procedures for production and process controls.

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