FDA WARNING_LETTER - MWT Materials, Inc. - April 28, 2015

On August 6, 2015, the FDA issued a Warning Letter to MWT Materials, Inc. following an inspection from April 22-28, 2015, which found their Accusorb MRI devices (radio frequency shielding blankets and body-part covers) to be adulterated and misbranded.

Key violations include: 1. **Failure to establish complaint handling procedures (21 CFR 820.198(a))**: No procedures were provided, lacking requirements for timely processing, oral complaint documentation, and MDR evaluation. 2. **Failure to establish design history files (DHF) (21 CFR 820.30(j))**: No DHFs were provided for Accusorb MRI devices, and design changes over six years were undocumented. 3. **Failure to adequately maintain a device master record (DMR) (21 CFR 820.181)**: Incomplete DMRs were provided, lacking device specifications, production process specifications, quality assurance procedures, and packaging/labeling specifications. 4. **Failure to develop written medical device reporting (MDR) procedures (21 CFR 803.17)**: No MDR procedures were provided to ensure timely reporting and investigation of death/serious injury events. 5. **Failure to report corrections or removals (21 CFR 806.10(a