Va. Kit Company Gets Closeout Letter on GMP Gaps, Unapproved Product

Kit and medical supply company H&H Associates has successfully resolved quality control issues, including a reported lack of premarket clearance for one product and multiple GMP violations, a close-out letter released by the FDA Dec. 20 shows. The letter recounts nine quality system violations identified during a Dec. 1, 2011, to Jan. 10, 2012, inspection of H&H’s Ordinary, Va., facility.
Devices & Diagnostics Letter