FDA Inspection 870748 — Goetze-Niemer Co Inc
The FDA completed an inspection of Goetze-Niemer Co Inc on March 19, 2014 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 19, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Kansas City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 12415 | 21 CFR 1271.260(e) | Temperature limits |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |