FDA Inspection 651076 — Geneva Laboratories, Inc
The FDA completed an inspection of Geneva Laboratories, Inc on March 11, 2010 in Elkhorn, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 11, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Elkhorn, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |