605929
Primrose Candy Co. — FEI 1412287
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 19, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1552 | 21 CFR 110.35(a) | Buildings/sanitary |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3610 | 21 CFR 211.160(b)(3) | Drug product sample |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4330 | 21 CFR 211.130(e) | Packaging line inspection documentation |
| 4380 | 21 CFR 211.198(b)(3) | Determination not to conduct investigation of complaint |
| 4576 | 21 CFR 211.192 | No written record of investigation |