FDA Inspection
Olsen MedicalOlsen Medical – FDA Inspection, Mar 9, 2010
Record Details
This FDA Inspection record concerns Olsen Medical, with an inspection on March 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Olsen Medical
- Inspection Date
- March 9, 2010
- Product Type
- Devices
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ID · b9b31830-cbf3-4ffe-b84f-45877d8b5a8d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 648580
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.100(a)(1)Analysis of data sources
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.100(a)(2)Investigation procedures
- 21 CFR 820.90(a)Nonconforming product evaluation/investigation
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
- 21 CFR 820.250(a)Appropriateness
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Other FDA inspections of Olsen Medical
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 25, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 17, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Olsen Medical
- FDA Inspection 942880 - 2015-08-25
- FDA Inspection 831331 - 2013-04-17
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