FDA WARNING_LETTER - naimco inc - August 24, 2011

On August 15-19 and 24, 2011, an FDA inspection of NAImco Inc., dba Rich-Mar, Inc. in Chattanooga, Tennessee, revealed that their Ultrasound/Stimulator Electro-Therapy devices and other products were adulterated under Section 501(h) of the Act [21 USC 351(h)]. The manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: - Failure to review and evaluate all complaints, particularly those involving patient shocks and burns, as required by 21 CFR 820.198(b). - Failure to establish adequate procedures for evaluating complaints for Medical Device Reporting (MDR) under 21 CFR Part 803, as required by 21 CFR 820.198(a)(3). - Inadequate corrective and preventive action (CAPA) procedures, including verification of effectiveness and dissemination of quality problem information (21 CFR 820.100(a)). - Lack of adequate rework procedures, documentation, and retesting (21 CFR 820.90(b)(2)). - Failure to ensure purchased products and services conform to requirements, including incomplete supplier evaluations and lack of an approved suppliers list (21