FDA Inspection 645205 — Cramer Products Inc
The FDA completed an inspection of Cramer Products Inc on January 20, 2010 in Gardner, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 20, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gardner, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 2200 | 21 CFR 211.186(b)(4) | Variation in the Amount of Components Used |
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 3144 | 21 CFR 820.160(a) | Control/distribution procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3333 | 21 CFR 820.184(f) | Device identification, control numbers |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |