FDA Inspection 918332 — Lloyd Inc. of Iowa
The FDA completed an inspection of Lloyd Inc. of Iowa on February 20, 2015 in Shenandoah, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 20, 2015
- Fiscal Year
- 2015
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Shenandoah, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4316 | 21 CFR 211.84(d)(3) | Testing Containers & Closures Conformity with Specs |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |