FDA WARNING_LETTER - Phoenix Instruments, Inc. - August 01, 2012

On July 10-August 1, 2012, an FDA inspection of Phoenix Instruments, Inc. in Naperville, Illinois, revealed that the firm's relabeling and repackaging of Class I and Class II surgical instruments, including Mogen circumcision clamps, Debakey vascular clamps, Pratt uterine dilators, and Hoen nerve hooks, rendered them adulterated under 21 U.S.C. § 351(h). The firm's manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

The firm's August 21, 2012, response to the FDA 483 was deemed inadequate. Violations included: 1. Failure to validate the (b)(4) etching process to ensure it does not adversely affect products, as required by 21 CFR 820.75(a). 2. Failure to adequately maintain procedures for acceptance of incoming product, including incomplete documentation for Mogen Circumcision Clamp inspections and unmaintained "Receiving Inspection Procedure" forms, violating 21 CFR 820.80(b). 3. Failure to establish an adequate quality plan, with the President not formally approving the Quality Plan and previous procedures being overwritten, as required by 21 CFR 820.20(d).

Additionally, Mogen