FDA Inspection 575624 — Accutome, Inc
The FDA completed an inspection of Accutome, Inc on April 3, 2009 in Malvern, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 3, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Malvern, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |