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

January 1, 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, according to a close-out letter released by the FDA. 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.
Devices & Diagnostics Letter