FDA Inspection
Integrum AbIntegrum Ab – FDA Inspection, Aug 29, 2018
Record Details
This FDA Inspection record concerns Integrum Ab, with an inspection on August 29, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · a148b8f5-c13d-4eea-bfec-7008d38c1f63
Inspection Facts
- Inspection number
- 1063704
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Integrum Ab
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 8, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 21, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Integrum Ab
- FDA Inspection 1180268 - 2022-09-08
- FDA Inspection 926999 - 2015-05-21
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