FDA Inspection
Medical Compression Systems DBN Ltd.Medical Compression Systems DBN Ltd. – FDA Inspection, Jun 23, 2011
Record Details
This FDA Inspection record concerns Medical Compression Systems DBN Ltd., with an inspection on June 23, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 23, 2011
- Product Type
- Devices
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ID · d6fa5b28-f59f-4481-bb55-b0b5881063bc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 733859
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.180Availability
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(g)Design validation - production units
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Other FDA inspections of Medical Compression Systems DBN Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medical Compression Systems DBN Ltd.
- FDA Inspection 791808 - 2012-07-11
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