FDA Inspection 660821 — Aurora Healthcare US Corp
The FDA completed an inspection of Aurora Healthcare US Corp on May 7, 2010 in Danvers, MA. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 7, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Danvers, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3323 | 21 CFR 820.170(b) | Installer records |