FDA Inspection 697857 — Gateway Products, Incorporated
The FDA completed an inspection of Gateway Products, Incorporated on November 4, 2010 in Holly, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 4, 2010
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Holly, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15549 | 21 CFR 111.260(i) | Batch record - specifications |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15734 | 21 CFR 111.360 | Manufacturing operations - sanitation |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |