FDA Inspection 858645 — Smiths Medical ASD, Inc.
The FDA completed an inspection of Smiths Medical ASD, Inc. on December 10, 2013 in Rockland, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 10, 2013
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rockland, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |