FDA Inspection 1113205 — Desarrollo E Investigacion Medica Aragonesa SL
The FDA completed an inspection of Desarrollo E Investigacion Medica Aragonesa SL on December 19, 2019 in Calatayud. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 19, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Calatayud (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |