FDA Inspection
Pos-T-Vac, LLC.Pos-T-Vac, LLC. – FDA Inspection, Mar 14, 2017
Record Details
This FDA Inspection record concerns Pos-T-Vac, LLC., with an inspection on March 14, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 742bed06-06f9-48c6-b60f-1977bc63b9af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006140
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Pos-T-Vac, LLC.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 30, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 29, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pos-T-Vac, LLC.
- FDA Inspection 1238102 - 2024-04-30
- FDA Inspection 815984 - 2013-01-29
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