FDA Inspection 1008525 — Canadian Hospital Specialties Ltd.
The FDA completed an inspection of Canadian Hospital Specialties Ltd. on Feb 2, 2017 in Oakville. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 2, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oakville (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |