AGFA healthcare Corp. – FDA Warning Letter, Jan 6, 2011

On April 15, 2011, the FDA issued a Warning Letter to AGFA Healthcare NV following an inspection from November 30, 2010, to January 6, 2011, at their Westerly, RI facility. The inspection determined that AGFA Healthcare manufactures AGFA IMPAX Cardiovascular Suites, classified as medical devices.

The inspection revealed significant violations, leading to the devices being misbranded under section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act. Key violations include:

1. **Medical Device Reporting (MDR) Deficiencies (21 CFR Part 803):** * Failure to submit all reasonably known information in MedWatch 3500A Forms (21 CFR 803.50(b)(1)), specifically omitting patient respiratory failure and death after delayed heparin treatment in MDR (b)(4). * Failure to indicate the outcome of adverse events in Form 3500A, Block B (21 CFR 803.52(b)(2)), as seen in MDR (b)(4) where patient death was not noted. * Failure to correctly indicate the type of reportable event in Form 3500A, Block H1 (21 CFR 803.52(f)(1)), with inconsistent reporting (e.