FDA Inspection
Agb Inc.Agb Inc. – FDA Inspection, Apr 21, 2009
Record Details
This FDA Inspection record concerns Agb Inc., with an inspection on April 21, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Agb Inc.
- Inspection Date
- April 21, 2009
- Product Type
- Devices
View Company Profile
ID · a8957814-1fa8-4c7a-9ad0-96bbd9b8e12a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 577636
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.198(a)General
- 21 CFR 820.20Management responsibility
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.184(f)Device identification, control numbers
- 21 CFR 803.17Lack of Written MDR Procedures
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