FDA Inspection
Tetracore, Inc.Tetracore, Inc. – FDA Inspection, May 28, 2009
Record Details
This FDA Inspection record concerns Tetracore, Inc., with an inspection on May 28, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tetracore, Inc.
- Inspection Date
- May 28, 2009
- Product Type
- Devices
View Company Profile
ID · d5d7daf2-2014-43fb-8d03-1588fb17664f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 584280
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.30(b)Establish the design and development plan
- 21 CFR 820.30(e)Design review procedures - personnel
- 21 CFR 820.75(a)Documentation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Tetracore, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 8, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 6, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 14, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 28, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Tetracore, Inc.
- FDA Inspection 1256176 - 2024-12-05
- FDA Inspection 1167551 - 2022-04-08
- FDA Inspection 1111969 - 2019-12-06
- FDA Inspection 842712 - 2013-08-14
- FDA Inspection 669356 - 2010-06-28
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