978485
B & J Group — FEI 3010096700
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 26, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Morrisville, PA (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 17749 | 21 CFR 212.30(a) | Prevention of contamination |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3574 | 21 CFR 211.101(b)(1) | Subdivided component container identification |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |
| 4379 | 21 CFR 211.188(b)(1) | Dates not included for each significant step |