Inspections, Compliance, Enforcement, and Criminal Investigations
Hyperbaric For Life LLC - Close Out Letter 7/15/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
RETURN RECEIPT REQUESTED
July 15, 2011
Mr. Frederick Ryder
Hyperbaric For Life, LLC
2904 West Belmont Ave
Phoenix, AZ 85051
Dear Mr. Ryder:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter WL # 18-10, dated 05/20/10. Based on our evaluation, it appears that you have generally addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
Please note, however, that in your corrective action, MDR Procedure, Rev. 001, your language does not fully correlate with the Code of Federal Regulations, 21 CFR Part 803 as follows:
1. You state "malfunctions known to have been associated with patient injury or death within the previous two years", 21 CFR Part 803.50(a) states "serious injury" and makes no mention of two years.
2. You state ''patients are considered injured by report or if any type of medical intervention ... "
Please note that the intervention may be medical or surgical.
3. You procedure lacks language which fits 21 CFR Part 803.50(a)(2) which states that "a device that you market has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur".
4. Your procedure states a "20 Day Deadline ", 21 CFR Part 803.10(c) states to "submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of reportable death, serious injury, or malfunction".
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Please revise your MDR procedure as noted above or where appropriate and send the revised SOP to:
Dr. Raymond W. Brullo, Compliance Officer
FDA, Los Angeles District Office
Irvine, CA 92612
Alonza E. Cruse