FDA Inspection 683799 — EXL Laboratories, LLC.
The FDA completed an inspection of EXL Laboratories, LLC. on Oct 1, 2010 in Minneapolis, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 1, 2010
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Minneapolis, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4316 | 21 CFR 211.84(d)(3) | Testing Containers & Closures Conformity with Specs |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |