FDA Inspection 1219346 — B & J Group
The FDA completed an inspection of B & J Group on Oct 2, 2023 in Morrisville, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 2, 2023
- Fiscal Year
- 2024
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Morrisville, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 2023 | 21 CFR 211.188(b)(11) | Identification of Persons Performing Significant Steps |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |