FDA Inspection
MWT Materials, Inc.MWT Materials, Inc. – FDA Inspection, Apr 28, 2015
Record Details
This FDA Inspection record concerns MWT Materials, Inc., with an inspection on April 28, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MWT Materials, Inc.
- Inspection Date
- April 28, 2015
- Product Type
- Devices
View Company Profile
ID · d4139958-d436-4015-b5d5-a542783ccf2c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 923212
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.