FDA Inspection
Ormco/SybronendoOrmco/Sybronendo – FDA Inspection, Jun 29, 2011
Record Details
This FDA Inspection record concerns Ormco/Sybronendo, with an inspection on June 29, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ormco/Sybronendo
- Inspection Date
- June 29, 2011
- Product Type
- Devices
View Company Profile
ID · 8c83609a-4bf6-48cb-8766-8911fd4cce73
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 731636
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.180(b)Retention period
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Other FDA inspections of Ormco/Sybronendo
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2017 | Not classified | Los Angeles District Office | |
| January 24, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 20, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ormco/Sybronendo
- FDA Inspection 1031062 - 2017-07-21
- FDA Inspection 763710 - 2012-01-24
- FDA Inspection 641489 - 2010-01-20
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