FDA WARNING_LETTER - Merge Healthcare, Inc. - July 27, 2015

The FDA issued a Warning Letter to Merge Healthcare, Inc. following an inspection from June 3 to July 27, 2015, at their Hartland, Wisconsin facility. The inspection revealed that the firm manufactures medical device software, including PACS and PDM systems, which are adulterated under section 501(h) of the Act due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. Failure to review and evaluate complaints involving possible device failure (21 CFR 820.198(c)), with specific examples cited. The firm's response was inadequate, lacking an updated procedure and commitment to retrospective review. 2. Failure to establish adequate complaint handling procedures by a formally designated unit (21 CFR 820.198(a)). The firm's SOP QS-26 lacked assigned responsibility, and their response did not provide an updated procedure or implementation timeframe. 3. Failure to adequately establish design validation procedures (21 CFR 820.30(g)), specifically allowing unvalidated devices (e.g., Merge HEMO V10.0) to be shipped for clinical use under "Limited Availability." The firm's response was inadequate, lacking an updated procedure, timeframe, and clarity on other affected projects. 4. Failure to document design review results in the design