FDA Inspection 1261620 — Advanced Monitored Caregiving, Inc.
The FDA completed an inspection of Advanced Monitored Caregiving, Inc. on Jan 31, 2025 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 31, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |