FDA Inspection
AGFA Healthcare CorporationAGFA Healthcare Corporation – FDA Inspection, Sep 29, 2016
Record Details
This FDA Inspection record concerns AGFA Healthcare Corporation, with an inspection on September 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- AGFA Healthcare Corporation
- Inspection Date
- September 29, 2016
- Product Type
- Devices
View Company Profile
ID · eca63bfb-ecc3-4816-abf6-48867bb30bef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988464
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of AGFA Healthcare Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 6, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for AGFA Healthcare Corporation
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.