FDA Inspection 961724 — Ludlow Technical Products Canada, Ltd. (A Division Of Cardinal Health LLC)
The FDA completed an inspection of Ludlow Technical Products Canada, Ltd. (A Division Of Cardinal Health LLC) on Jan 28, 2016 in Gananoque. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 28, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Gananoque (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 3264 | 21 CFR 820.250(b) | Sampling methods - Lack of or inadequate procedures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |