FDA WARNING_LETTER - Kral X-ray Inc. - January 17, 2013

This FDA Warning Letter (13-ATL-09) was issued to Mr. and Mrs. Kral following an inspection of their firm in Buford, GA, from January 15-17, 2013. The firm is an assembler of diagnostic x-ray systems, defined as devices under the Federal Food, Drug, and Cosmetic Act.

The inspection revealed several violations of 21 CFR 1020.30(d) and Section 538 of the Act. The firm failed to provide manufacturer's instructions/specifications for installations and documentation of adherence to these instructions during assembly or reassembly of diagnostic x-ray systems.

Furthermore, the firm failed to file FORM FDA 2579 (Report of Assembly of a Diagnostic X-Ray System) for multiple assembled systems or replaced components, with installation dates ranging from 2008 to 2012. The firm also failed to provide copies of FDA 2579 forms to purchasers and appropriate State agencies within 15 days of assembly completion for several installations. Additionally, some filed FDA 2579 forms were found to be inaccurate and incomplete, lacking installation dates or other required information.

While the firm's response to the FDA 483 addressed most violations, concerns remain regarding the sustainability of corrective actions due to a history of similar noncompliance, evidenced by a 2003 warning letter. The FDA