FDA Inspection
Gaven MedicalGaven Medical – FDA Inspection, May 8, 2009
Record Details
This FDA Inspection record concerns Gaven Medical, with an inspection on May 8, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gaven Medical
- Inspection Date
- May 8, 2009
- Product Type
- Devices
View Company Profile
ID · 57302d0a-e5d4-4f5b-a081-07c6396341e2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 581442
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(a)(2)Production monitoring and control
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(d)(2)Review of data and documentation
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.70(g)(1)Activity documentation
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.184(d)Acceptance records
- 21 CFR 820.184(f)Device identification, control numbers
- 21 CFR 820.90(b)(1)Documentation of disposition, justification, signature
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