FDA Inspection 1014903 — Aea Srl
The FDA completed an inspection of Aea Srl on Jun 15, 2017 in Maiolati Spontini. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 15, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Maiolati Spontini (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |