FDA Inspection
Marel CorporationMarel Corporation – FDA Inspection, Jun 24, 2014
Record Details
This FDA Inspection record concerns Marel Corporation, with an inspection on June 24, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Marel Corporation
- Inspection Date
- June 24, 2014
- Product Type
- Devices
View Company Profile
ID · 5ffd9198-7475-4f28-b56a-d61db1f8acc5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 885647
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Marel Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 13, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Marel Corporation
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