FDA Inspection 1068666 — Reckitt Benckiser LLC
The FDA completed an inspection of Reckitt Benckiser LLC on October 12, 2018 in Jefferson, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 12, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Jefferson, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |