Closeout: Va. Company Resolves Multiple Documentation Concerns

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. However, further negotiations with the FDA confirmed the product was covered under the agency’s convenience kit guidance and did not require a 510(k), company President Paul Harder said.

The letter followed an inadequate response by H&H to the Form 483 and two further responses that arrived outside the FDA’s 15-day response window and were not reviewed. The first response was rejected because it was not clear if a procedure chart for a new quality system regulation had been implemented, according to the letter.

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