FDA Inspection 832020 — Abbott Medical
The FDA completed an inspection of Abbott Medical on May 7, 2013 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
- May 7, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Arecibo, PR (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |