FDA Inspection
Octostop IncOctostop Inc – FDA Inspection, Aug 25, 2011
Record Details
This FDA Inspection record concerns Octostop Inc, with an inspection on August 25, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Octostop Inc
- Inspection Date
- August 25, 2011
- Product Type
- Devices
View Company Profile
ID · f2685169-cf19-4a36-a119-6dea62e8c069
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 744647
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.25(b)Training records
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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