FDA Inspection
Integrum AbIntegrum Ab – FDA Inspection, Sep 8, 2022
Record Details
This FDA Inspection record concerns Integrum Ab, with an inspection on September 8, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Integrum Ab
- Inspection Date
- September 8, 2022
- Product Type
- Devices
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ID · f4d1a67e-a5ee-469c-b105-78bd7a398df5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1180268
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.72(b)Remedial action
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Integrum Ab
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2018 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| May 21, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Integrum Ab
- FDA Inspection 1063704 - 2018-08-29
- FDA Inspection 926999 - 2015-05-21
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