FDA Inspection
Proactive Medical ProductsProactive Medical Products – FDA Inspection, Nov 9, 2021
Record Details
This FDA Inspection record concerns Proactive Medical Products, with an inspection on November 9, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Proactive Medical Products
- Inspection Date
- November 9, 2021
- Product Type
- Devices
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ID · 9d439ff8-e131-4d27-8d26-df1d3ada913d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1156275
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Proactive Medical Products
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 25, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 20, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Proactive Medical Products
- FDA Inspection 1266520 - 2025-03-25
- FDA Inspection 1039068 - 2017-12-20
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