FDA Inspection 826816 — Ambulatory Monitoring Inc.
The FDA completed an inspection of Ambulatory Monitoring Inc. on April 5, 2013 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
- April 5, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ardsley, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |