FDA Inspection 697628 — AmniSure International LLC
The FDA completed an inspection of AmniSure International LLC on November 18, 2010 in Boston, MA. 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
- November 18, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Boston, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 537 | 21 CFR 820.70(a) | Production processes |