Aqueduct Medical, Inc. – FDA Warning Letter, May 17, 2010
On December 22, 2010, the FDA issued a Warning Letter to Aqueduct Medical, Inc. following an inspection from April 22 to May 17, 2010. The inspection revealed that the AqueCool™ Rapid Recovery System, AqueVest™ device, and AqueCool™ Masque device are adulterated and misbranded.
The devices are adulterated because Aqueduct Medical, Inc. lacks an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. They are misbranded due to failure to submit a 510(k) premarket notification, marketing claims of "rapid recovery" and "accelerated healing" that exceed the limitations for Water circulating hot or cold packs (21 CFR 890.5720), and failure to furnish required information under Medical Device Reporting (MDR) regulations (21 CFR Part 803).
Furthermore, the devices are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods do not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). Violations include: * Failure to validate the radio frequency welding process (21 CFR 820.75(a)). * Inadequate procedures for
ID · e99a43b5-3b2f-4474-a71a-1edf1b39f222
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