FDA Inspection
Interlab S.r.l.Interlab S.r.l. – FDA Inspection, Oct 25, 2012
Record Details
This FDA Inspection record concerns Interlab S.r.l., with an inspection on October 25, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Interlab S.r.l.
- Inspection Date
- October 25, 2012
- Product Type
- Devices
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ID · f5be514b-4821-4b43-8874-f2314e9715c6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 806255
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
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Other FDA inspections of Interlab S.r.l.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Interlab S.r.l.
- FDA Inspection 914308 - 2015-01-29
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