FDA Inspection 594663 — Abbott Diagnostics International, Ltd.
The FDA completed an inspection of Abbott Diagnostics International, Ltd. on June 17, 2009 in Barceloneta, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 17, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Barceloneta, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |