FDA Inspection 1076112 — B & J Group
The FDA completed an inspection of B & J Group on Dec 27, 2018 in Morrisville, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 27, 2018
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Morrisville, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1725 | 21 CFR 211.134(c) | Examinations documented |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |