FDA Inspection 653998 — Abbott Molecular, Inc.
The FDA completed an inspection of Abbott Molecular, Inc. on Mar 10, 2010 in Des Plaines, IL. 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
- Mar 10, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Des Plaines, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3299 | 21 CFR 820.100(a)(1) | Procedure for analysis of data sources |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |