FDA WARNING_LETTER - Capillus LLC - May 16, 2013

On September 20, 2013, the FDA issued a Warning Letter to Capillus, LLC, following an inspection from April 26 to May 16, 2013. The inspection determined that Capillus, LLC, imports and manufactures the Capillus272 laser therapy system, which is classified as a medical device and electronic product.

The Capillus272 system was found to be adulterated under Section 501(h) of the Act due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Violations included: * Failure to establish purchasing control procedures (21 CFR 820.50). * Lack of written complaint procedures and failure to investigate device failures (21 CFR 820.198(a), 820.198(c)). * Absence of corrective and preventive action procedures (21 CFR 820.100(a)). * Failure to identify product acceptance status (21 CFR 820.86). * Lack of procedures for controlling labeling activities and maintaining Device History Records (DHRs) (21 CFR 820.120, 820.184). * Absence of a Device Master Record (DMR) (21 CFR 8