Closeout: Va. Company Resolves Multiple Documentation Concerns

January 8, 2013
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 shows. The original warning letter, dated April 30, 2012, and issued by the agency’s Baltimore district office, said the H&H Emergency Criothyrotomy Kit was being marketed without 510(k) clearance and advised the company to apply for it.
The GMP Letter