FDA Inspection
Prestige MedicalPrestige Medical – FDA Inspection, Oct 24, 2019
Record Details
This FDA Inspection record concerns Prestige Medical, with an inspection on October 24, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Prestige Medical
- Inspection Date
- October 24, 2019
- Product Type
- Devices
View Company Profile
ID · 77e016c2-cf69-423b-ba8e-6335b5868bc7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1107415
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.86Acceptance status
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Prestige Medical
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 13, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 8, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 28, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 10, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Prestige Medical
- FDA Inspection 1271421 - 2025-01-23
- FDA Inspection 1197590 - 2023-01-13
- FDA Inspection 974724 - 2016-06-08
- FDA Inspection 846664 - 2013-08-28
- FDA Inspection 651875 - 2010-03-10
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