FDA WARNING_LETTER - Life Force of Tampa, LLC - January 28, 2014

On May 21, 2014, the FDA issued a Warning Letter to Life Force of Tampa, LLC, following an inspection from January 27-28, 2014. The inspection revealed that the firm's LIFE FORCE® chamber is a medical device and is adulterated under 21 U.S.C. § 351(h) due to non-conformity with cGMP requirements of 21 CFR Part 820 (Quality System regulation).

Key violations include: 1. Failure to establish and maintain design control procedures (21 CFR § 820.30(a)(1)), lacking documentation for labeling requirements. 2. Failure to establish and maintain corrective and preventive action procedures (21 CFR § 820.100(a)). 3. Failure to establish and maintain complaint handling procedures and files (21 CFR § 820.198(a)). 4. Failure to develop, conduct, control, and monitor production processes to ensure device conformity to specifications (21 CFR § 820.70(a)), with provided procedures lacking adequate instructions and technical specifications. 5. Failure to establish and maintain procedures for acceptance activities, including final inspection and incoming inspection of components (21 CFR § 820.80(a)).

The device is also misbranded under 21 U.S