FDA WARNING_LETTER - AGFA Healthcare Corp. - April 11, 2014

An FDA inspection of AGF A Healthcare Corporation in Greenville, SC, from March 3 to April 11, 2014, revealed that the firm's medical devices, including the DX-D100 X-Ray machine, are adulterated under Section 501(h) of the Act due to non-conformity with Quality System (QS) regulations (21 CFR Part 820). The inspection identified significant violations, including inadequate documentation of corrective and preventive action (CAPA) activities (21 CFR 820.100(b)), with recurring problems like system polling failures and image loss remaining uncorrected. The firm also failed to timely review, evaluate, and investigate numerous complaints (21 CFR 820.198(c)), leaving hundreds open. Additionally, process control procedures for refurbishing DX-D100 x-ray machines were incomplete, lacking inspection requirements and quality review (21 CFR 820.70(a)). The DX-D110 X-ray machine and IMPAX CV Reporting were found misbranded under Section 502(t)(2) for failing to report device malfunctions likely to cause death or serious injury within 30 days, as required by 21 CFR 803.50(a)(2). While the firm's response outlined corrective actions for MDRs, FDA requested further details and status updates for CAPA, complaint handling, and refurbishment process improvements, with specific timelines for completion. Failure to promptly correct these violations could result in regulatory actions such as seizure, injunction, and civil money penalties. The firm must provide a comprehensive written response within fifteen business days detailing corrective actions and prevention plans.