FDA Inspection
Arriol International Corp.Arriol International Corp. – FDA Inspection, Apr 12, 2012
Record Details
This FDA Inspection record concerns Arriol International Corp., with an inspection on April 12, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Arriol International Corp.
- Inspection Date
- April 12, 2012
- Product Type
- Devices
View Company Profile
ID · ab168ecb-db5e-4abe-bcff-f2b13c56a7f3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 778735
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Arriol International Corp.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 14, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 22, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Arriol International Corp.
- FDA Inspection 1251375 - 2024-09-12
- FDA Inspection 948544 - 2015-10-14
- FDA Inspection 830404 - 2013-03-22
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