FDA Inspection 1002301 — Royal Chemical Company
The FDA completed an inspection of Royal Chemical Company on February 28, 2017 in E Stroudsburg, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 28, 2017
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- E Stroudsburg, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2405 | 21 CFR 211.194(a)(7) | Identification of Person Performing the Testing |
| 3581 | 21 CFR 211.101(d) | Verification of component addition |