FDA Inspection
Desarrollo E Investigacion Medica Aragonesa SLDesarrollo E Investigacion Medica Aragonesa SL – FDA Inspection, Dec 19, 2019
Record Details
This FDA Inspection record concerns Desarrollo E Investigacion Medica Aragonesa SL, with an inspection on December 19, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 19, 2019
- Product Type
- Devices
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ID · d0db1448-1221-417f-8906-7f33508099b6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1113205
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Desarrollo E Investigacion Medica Aragonesa SL
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 3, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Desarrollo E Investigacion Medica Aragonesa SL
- FDA Inspection 959960 - 2016-01-27
- FDA Inspection 888372 - 2014-07-03
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