FDA Inspection 655882 — MedMira Laboratories Inc.
The FDA completed an inspection of MedMira Laboratories Inc. on Mar 25, 2010 in Halifax. 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). 10 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 25, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Halifax (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3333 | 21 CFR 820.184(f) | Device identification, control numbers |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3377 | 21 CFR 820.198(e)(3) | Device identification and control number |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |
| 3702 | 21 CFR 820.250(a) | Appropriateness |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |