FDA Inspection 1014680 — Global Marketing Enterprises, Inc.
The FDA completed an inspection of Global Marketing Enterprises, Inc. on June 14, 2017 in Chicago, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 14, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16083 | 21 CFR 111.35(b)(6) | Documentation - equipment functions; intended use |
| 904 | 21 CFR 123.6(b) | No HACCP plan |
| 945 | 21 CFR 123.12(a)(2) | Importer verification |