FDA Inspection 874498 — Abbott Medical
The FDA completed an inspection of Abbott Medical on Apr 11, 2014 in Arecibo, PR. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 11, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Arecibo, PR (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |