FDA Inspection 783015 — Primus Corporation
The FDA completed an inspection of Primus Corporation on May 18, 2012 in Kansas City, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 18, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kansas City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3230 | 21 CFR 820.70(i) | Validation of changes to automated process software |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 9129 | 21 CFR 809.10(b)(5)(iv) | Storage-instructions (no manipulation of reagent) |