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

Source: https://www.globalkeysolutions.net/records/warning_letter/mwt-materials-inc/740e9678-91d3-406f-98c4-db1f5c4cbad0

> FDA WARNING_LETTER for MWT Materials, Inc. on April 28, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: MWT Materials, Inc.
- Inspection Date: 2015-04-28
- Product Type: Devices
- Office Name: New Jersey District Office
- Summary: 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

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/diana-amador-toro/66f3f6c5-4cfe-4f40-b4d4-d24ed4618e64)

Company: https://www.globalkeysolutions.net/companies/mwt-materials-inc/26d629c4-69e6-458a-92e5-00f1565fa40e

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248