FDA WARNING_LETTER - Elite Massagers, LLC. - March 27, 2014

On March 27, 2014, an FDA inspection of Elite Massagers, LLC, identified the firm as an initial importer of Mono Elite Massager and Multi Elite Massager devices. The inspection revealed these devices are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Specific QS violations include: 1. Failure to establish procedures for acceptance activities (21 CFR 820.80(a)). 2. Failure to establish procedures for corrective and preventive actions (21 CFR 820.100(a)). 3. Failure to establish procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198). 4. Failure to establish procedures to ensure purchased products and services conform to requirements, including supplier control (21 CFR 820.50). 5. Failure to establish procedures for quality audits (21 CFR 820.22). 6. Failure to establish procedures for management reviews (21 CFR 820.20(c)).

The firm's responses dated April 30, 2014, and June 17, 2014, were deemed