FDA Inspection
General Project s.r.l.General Project s.r.l. – FDA Inspection, Jan 20, 2011
Record Details
This FDA Inspection record concerns General Project s.r.l., with an inspection on January 20, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- General Project s.r.l.
- Inspection Date
- January 20, 2011
- Product Type
- Devices
View Company Profile
ID · 7cc4d853-6c04-4698-8045-d512e1b41c36
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 715640
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of General Project s.r.l.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 3, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for General Project s.r.l.
- FDA Inspection 906308 - 2014-12-03
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