FDA WARNING_LETTER - Genesis Biosystems, Inc - June 01, 2015

An FDA inspection of Genesis Biosystems, Inc. from December 2014 to June 2015 revealed significant violations regarding their DermaFrac Micro-channeling System and Lipivage Fat Harvest and Transfer System. The DermaFrac System was found adulterated (21 U.S.C. § 351(f)(1)(B)) for lacking an approved PMA or IDE, and misbranded (21 U.S.C. § 352(o)) for failing to submit a 510(k) premarket notification. Its micro-channeling technology, differing from 510(k)-exempt dermabrasion devices, raised new safety questions.

Both devices were adulterated (21 U.S.C. § 351(h)) due to non-conformity with the Quality System regulation (21 CFR Part 820). Specific deficiencies included failure to validate computer software (21 CFR 820.70(i)) and inadequate Device History Record (DHR) procedures (21 CFR 820.184). The firm's January 2015 response was deemed inadequate, with corrective actions still ongoing.

Genesis Biosystems must immediately cease activities causing misbranding/adulteration of the DermaFrac System. A written response within fifteen business days is required, detailing corrective actions, prevention plans, and a timetable. Non-compliance risks regulatory actions like seizure, injunction, and civil money penalties. The letter also highlighted that Lipivage may require CBER premarket review, and DermaFrac's topical solution claims imply drug intended uses, requiring drug provision compliance.