FDA Inspection
BCIW IncBCIW Inc – FDA Inspection, Jan 21, 2010
Record Details
This FDA Inspection record concerns BCIW Inc, with an inspection on January 21, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BCIW Inc
- Inspection Date
- January 21, 2010
- Product Type
- Devices
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ID · 3308bb89-d73e-4c15-aca6-ea0c0f1326ae
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 640189
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)General
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.75(a)Documentation
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Other FDA inspections of BCIW Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 23, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for BCIW Inc
- FDA Inspection 773860 - 2012-03-23
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