FDA WARNING_LETTER - Atlanta Dental Supply Company, Inc . - June 21, 2012

On September 5, 2012, the FDA issued a Warning Letter to Atlanta Dental Supply Company, Inc. following an inspection from June 19-21, 2012. The inspection determined the firm is an assembler of diagnostic x-ray equipment.

The firm failed to file Report of Assembly of a Diagnostic X-Ray System, FORM FDA 2579, for each certified diagnostic x-ray system assembled, as required by 21 CFR 1020.30(d)(1). This includes 30 specific installations in Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee, with installation dates ranging from March 21, 2007, to May 23, 2012. Additionally, the firm failed to provide the purchaser and submit a copy of the Report of Assembly for three diagnostic x-ray assemblies performed at a specific location, as required by 21 CFR 1020.30(d).

The firm's July 9, 2012, response was deemed inadequate for not identifying corrective and preventive actions. The FDA requires the firm to review all installation records for the past five years to identify all unreported installations. For all identified installations, the firm must provide evidence of compliance with 21 CFR Sections 1020.30-32 and submit a Corrective Action Plan (CAP)