FDA Inspection 608879 — Mesa Laboratories, Inc., Bozeman Manufacturing Facility
The FDA completed an inspection of Mesa Laboratories, Inc., Bozeman Manufacturing Facility on Aug 5, 2009 in Bozeman, MT. 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
- Aug 5, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bozeman, MT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3156 | 21 CFR 820.181(b) | DMR production process specifications |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3227 | 21 CFR 820.70(g)(1) | Activity documentation |