FDA Inspection 1155074 — Advanced Cooling Therapy LLC
The FDA completed an inspection of Advanced Cooling Therapy LLC on Oct 22, 2021 in Boston, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Oct 22, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Boston, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3696 | 21 CFR 820.100(b) | Documentation |