FDA WARNING_LETTER - Hyperbaric for Life LLC - February 18, 2010

On May 20, 2010, the FDA issued a Warning Letter to Hyperbaric for Life LLC, following an inspection from February 9-18, 2010, at their Phoenix, Arizona facility. The inspection determined that the firm manufactures Hyperbaric Chambers, which are classified as medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act.

The inspection revealed that the hyperbaric chamber devices are misbranded under section 502(t)(2) of the Act because the firm failed to furnish material or information required by section 519 of the Act and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. A significant deviation identified was the failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.

The FDA requires prompt corrective action to address these violations. Failure to do so may result in regulatory actions including seizure, injunction, civil money penalties, and impact on federal contracts, premarket approval applications for Class III devices, and Certificates to Foreign Governments. Hyperbaric for Life LLC was instructed to provide a written response within fifteen working days detailing specific corrective steps, a plan to prevent recurrence, and a timetable for implementation, if applicable. The response should be sent to Daniel W. Cline, Acting Compliance Branch Director. The letter also