FDA Inspection
Primrose Medical Inc.Primrose Medical Inc. – FDA Inspection, Oct 26, 2022
Record Details
This FDA Inspection record concerns Primrose Medical Inc., with an inspection on October 26, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Primrose Medical Inc.
- Inspection Date
- October 26, 2022
- Product Type
- Devices
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ID · bc9ed0c7-7938-4286-abbf-42555f2fcd20
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1182299
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.100(b)Documentation
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.120(b)Labeling inspection - UDI
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Primrose Medical Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Primrose Medical Inc.
- FDA Inspection 1057152 - 2018-06-06
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