FDA Inspection
Gateway Products, IncorporatedGateway Products, Incorporated – FDA Inspection, Nov 4, 2010
Record Details
This FDA Inspection record concerns Gateway Products, Incorporated, with an inspection on November 4, 2010, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Inspection Date
- November 4, 2010
- Product Type
- Food/cosmetics
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ID · 2a9c2e56-719c-4477-9ada-c08822ef5d95
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 697857
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
16- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
Showing 10 of 16 citations.
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Other FDA inspections of Gateway Products, Incorporated
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 28, 2020 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| November 15, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 24, 2015 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 24, 2011 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Gateway Products, Incorporated
- FDA Inspection 1118079 - 2020-01-28
- FDA Inspection 991998 - 2016-11-15
- FDA Inspection 930954 - 2015-06-24
- FDA Inspection 741044 - 2011-08-24
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