H & H Associates – FDA Warning Letter, Jan 10, 2012

On April 30, 2012, the FDA issued a Warning Letter to H & H Associates following an inspection from December 1, 2011, to January 10, 2012, at their Ordinary, Virginia facility. The inspection determined that the firm manufactures the H & H Emergency Cricothyrotomy Kit and Chest Tube Insertion Kit, classified as devices under the Federal Food, Drug, and Cosmetic Act.

The H & H Emergency Cricothyrotomy Kit was found to be adulterated because the firm lacked an approved premarket approval (PMA) application or an investigational device exemption. It was also misbranded as the firm failed to notify the agency of its intent to introduce the device into commercial distribution via a 510(k) submission. The FDA noted that the kit requires 510(k) clearance, with documentation for performance, biocompatibility, clinical, and usability validation.

Both devices were deemed adulterated due to non-conformity with current good manufacturing practice requirements of the Quality System (QS) regulation (21 CFR Part 820). Specific QS violations included: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)), including design input, output, review, verification, validation, change, and transfer, and lack of a Design History File. 2. Failure to validate processes where results cannot be