FDA Inspection 1070919 — Prollenium Medical Technologies Inc.
The FDA completed an inspection of Prollenium Medical Technologies Inc. on Nov 1, 2018 in Aurora. 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
- Nov 1, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Aurora (Canada)
Additional details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |