FDA Inspection 671231 — Ambulatory Monitoring Inc.
The FDA completed an inspection of Ambulatory Monitoring Inc. on June 22, 2010 in Ardsley, NY. 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
- June 22, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ardsley, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |