FDA Inspection 678374 — Dandy Day Corporation
The FDA completed an inspection of Dandy Day Corporation on August 25, 2010 in Montrose, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 25, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Montrose, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15860 | 21 CFR 111.75(a)(2) | Component - confirm identity; specifications met |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15864 | 21 CFR 111.75(a)(2)(ii)(C) | Documentation - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15891 | 21 CFR 111.80(a) | Components packaging, labels received |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |