FDA Inspection
Elos Medtech Skara ABElos Medtech Skara AB – FDA Inspection, Mar 23, 2018
Record Details
This FDA Inspection record concerns Elos Medtech Skara AB, with an inspection on March 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e88cc382-923f-4894-a7b9-a9de53c57118
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1047590
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Elos Medtech Skara AB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 31, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Elos Medtech Skara AB
- FDA Inspection 1220692 - 2023-08-31
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