FDA Inspection
Avreo IncAvreo Inc – FDA Inspection, May 6, 2015
Record Details
This FDA Inspection record concerns Avreo Inc, with an inspection on May 6, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Avreo Inc
- Inspection Date
- May 6, 2015
- Product Type
- Devices
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ID · 7b90d4c9-2219-44e1-a444-7a0ddc171e52
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 932465
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.40(b)Change records, content
- 21 CFR 820.184DHR content
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Avreo Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Avreo Inc
- FDA Inspection 1223560 - 2023-09-12
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