FDA Inspection
Agfa Healthcare CorporationAgfa Healthcare Corporation – FDA Inspection, May 4, 2010
Record Details
This FDA Inspection record concerns Agfa Healthcare Corporation, with an inspection on May 4, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Agfa Healthcare Corporation
- Inspection Date
- May 4, 2010
- Product Type
- Devices
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ID · 3dc8d8df-78d8-4fb6-b0f2-89f8c5f5dd9f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 661434
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 803.18(b)(1)(i)Adverse events--all info not in file
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Agfa Healthcare Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Agfa Healthcare Corporation
- FDA Inspection 824872 - 2013-03-29
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