FDA Inspection 791475 — Primrose Candy Co.
The FDA completed an inspection of Primrose Candy Co. on July 25, 2012 in Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 17 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 25, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15746 | 21 CFR 111.210(h)(1) | Instructions; specifications; quality |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15893 | 21 CFR 111.80(c) | Specifications - representative samples; finished batch |
| 15911 | 21 CFR 111.90(b)(1) | In-process adjustment, component - no material review |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 4576 | 21 CFR 211.192 | No written record of investigation |