FDA Inspection 870594 — SC Johnson Professional CA Inc
The FDA completed an inspection of SC Johnson Professional CA Inc on February 27, 2014 in Brantford. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 27, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brantford (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |