FDA WARNING_LETTER - CNMC Company, Inc. - February 04, 2014

This FDA Warning Letter (2014-NOL-15) was issued to Best Medical International, Inc., following an inspection of CNMC Company, Inc. from January 27 to February 4, 2014. The inspection revealed that CNMC Company, Inc. manufactures radiologic quality assurance and linear accelerator accessories, which are classified as medical devices.

The devices, including Model 206 Dosimetry Electrometer, Water Phantom, TheraPro, and others, are adulterated because the firm lacks approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) applications. They are also misbranded due to failure to submit 510(k) premarket notifications and lack of proper establishment registration and device listing.

Furthermore, the devices are adulterated under Section 501(h) of the Act because manufacturing, packing, storage, or installation methods do not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Specific violations include: 1. Failure to ensure inspection, measuring, and test equipment is suitable and produces valid results (21 CFR 820.72(a)), exemplified by undocumented serial numbers of calibration equipment and use of uncalibrated multimeters. 2. Failure to establish and maintain a Design History File (DHF) for devices like the TheraPro