FDA Inspection 726276 — Accusync Medical Research Corp
The FDA completed an inspection of Accusync Medical Research Corp on May 24, 2011 in Milford, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 24, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Milford, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |