Smiths Medical Asd Inc – FDA Warning Letter, Mar 30, 2021

The FDA issued a Warning Letter to Smiths Medical ASD, Inc. following an inspection from February 23 – March 30, 2021, which identified significant violations. The firm, a specification developer and manufacturer of medical devices including blood warmers and infusion pumps, was found to have misbranded devices under section 502(t)(2) of the Act due to failures in furnishing required material or information under section 519 and 21 CFR Parts 803 and 806 (Medical Device Reporting and Reports of Corrections and Removals).

Key violations include: 1. **Failure to submit Medical Device Reports (MDRs)** within 30 calendar days for device malfunctions likely to cause or contribute to death or serious injury, as required by 21 CFR 803.50(a)(2). Examples cited were Medfusion Syringe Pump malfunctions (unexpected battery depletion) leading to a recall (Z-0610-2020). The firm's responses were deemed inadequate, with ongoing corrective actions lacking documentation of implementation. The revised procedure "Adverse Event Reporting – United State" (DP-20087, Revision 101) was deficient in establishing standardized review processes, timely transmission of complete MDRs, and adequate documentation/recordkeeping per 21 CFR 803.17(a)(2), 803.