FDA Inspection
Vidco, Inc.FDA Inspection 997382 - Vidco, Inc. - January 12, 2017
Record Details
This FDA Inspection record concerns Vidco, Inc., with an inspection on January 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Vidco, Inc.
- Inspection Date
- January 12, 2017
- Product Type
- Devices
View Company Profile
ID · 8949a4cd-4d46-418d-86d0-52dfe25ef663
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 997382
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vidco, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 8, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 3, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 2, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 18, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Vidco, Inc.
- FDA Inspection 1040758 - 2018-02-08
- FDA Inspection 864382 - 2014-02-03
- FDA Inspection 789445 - 2012-07-02
- FDA Inspection 676052 - 2010-08-18
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