Medical Quant USA Inc. – FDA Warning Letter, Sep 2, 2011

On January 9, 2012, the FDA issued a Warning Letter to Medical Quant USA following an inspection from August 15 to September 2, 2011. The inspection found that the firm's MR4, MR4 Activ, TQ Solo, and TQ Solo Pro Infrared Lamps are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

Violations include: 1. Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)). 2. Failure to document acceptance or rejection of incoming product (21 CFR 820.80(b)). 3. Failure to maintain records for uninvestigated complaints, including reasons and responsible individuals (21 CFR 820.198(b)). 4. Failure to establish adequate purchasing controls, specifically lacking supplier notification agreements for product changes (21 CFR 820.50(b)). 5. Failure to establish and maintain rework procedures, including retesting and reevaluation (21 CFR 820.90(b)(2)). 6. Failure to ensure labeling is examined for accuracy and documented before release (21 CFR 820