FDA Inspection
Vacumed, Div of Vacumetrics IncVacumed, Div of Vacumetrics Inc – FDA Inspection, Jun 9, 2016
Record Details
This FDA Inspection record concerns Vacumed, Div of Vacumetrics Inc, with an inspection on June 9, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 9, 2016
- Product Type
- Devices
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ID · a2c6ccc0-2dd2-416d-8f20-3e2ae9a0bb20
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 972730
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vacumed, Div of Vacumetrics Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 21, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 1, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 11, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Vacumed, Div of Vacumetrics Inc
- FDA Inspection 1220537 - 2023-09-13
- FDA Inspection 1118657 - 2020-02-21
- FDA Inspection 808234 - 2012-11-01
- FDA Inspection 653240 - 2010-03-11
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