947450
Kimball Electronics - Indianapolis — FEI 3004598644
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 16, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |