FDA Inspection
FSSB Chirurgische Nadeln GmbhFDA Inspection 628165 - FSSB Chirurgische Nadeln Gmbh - October 22, 2009
Record Details
This FDA Inspection record concerns FSSB Chirurgische Nadeln Gmbh, with an inspection on October 22, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 22, 2009
- Product Type
- Devices
View Company Profile
ID · 75cadc30-a9da-4d49-8749-43ce57365fe6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 628165
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.72(b)(1)Calibration standard traceability
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.100(a)(4)Verify, validate change {see also 820.100(a)}
Full citation text and observation details available on the Dashboard.
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 |
| September 20, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for FSSB Chirurgische Nadeln Gmbh
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.