FDA Inspection 1155204 — Cochlear Americas Inc.
The FDA completed an inspection of Cochlear Americas Inc. on Oct 21, 2021 in Lone Tree, CO. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 21, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Lone Tree, CO (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14511 | 21 CFR 812.2(b) | Abbreviated requirements / non-significant risk study |