FDA Inspection
Abbott Point Of Care Inc.Abbott Point Of Care Inc. – FDA Inspection, Aug 11, 2010
Record Details
This FDA Inspection record concerns Abbott Point Of Care Inc., with an inspection on August 11, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Abbott Point Of Care Inc.
- Inspection Date
- August 11, 2010
- Product Type
- Devices
View Company Profile
ID · a5c0b030-4c3a-44cf-9998-edfc88fc2c94
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 677548
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
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Other FDA inspections of Abbott Point Of Care Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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