FDA Inspection 1049779 — Cirrus Healthcare Products, LLC
The FDA completed an inspection of Cirrus Healthcare Products, LLC on Apr 26, 2018 in East Dorset, VT. 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
- Apr 26, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- East Dorset, VT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |