FDA Inspection
FSSB Chirurgische Nadeln GmbhFDA Inspection 803114 - FSSB Chirurgische Nadeln Gmbh - September 20, 2012
Record Details
This FDA Inspection record concerns FSSB Chirurgische Nadeln Gmbh, with an inspection on September 20, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 20, 2012
- Product Type
- Devices
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ID · 3f7790eb-d794-47b7-bf4b-88128a086929
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 803114
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.70(i)Documentation of software validation
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Other FDA inspections of FSSB Chirurgische Nadeln Gmbh
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 22, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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