FDA Inspection
Gotera, Inc. dba Mama Lycha Foods, Inc.Gotera, Inc. dba Mama Lycha Foods, Inc. – FDA Inspection, May 12, 2023
Record Details
This FDA Inspection record concerns Gotera, Inc. dba Mama Lycha Foods, Inc., with an inspection on May 12, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Person
- Patrick J. Legler
View Company Profile
ID · e2ed8c90-c351-4a9c-9bc9-f54324be62bb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1205097
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 1.506(e)(1)Verification activity before import, periodically
- 21 CFR 1.506(d)(1)(i)Verification activity assurance
- 21 CFR 1.502(a)Develop FSVP
- 21 CFR 1.505(a)(2)Evaluation - performance, risk
- 21 CFR 1.509(a)Identification - entry
- 21 CFR 1.506(a)(1)Approved supplier procedures - importer established
- 21 CFR 1.502(a)Develop FSVP
- 21 CFR 1.505(a)(2)Evaluation - performance, risk
- 21 CFR 1.506(a)(1)Approved supplier procedures - importer established
- 21 CFR 1.506(d)(1)(i)Verification activity assurance
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Other FDA inspections of Gotera, Inc. dba Mama Lycha Foods, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 6, 2024 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| September 12, 2022 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| September 28, 2017 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| December 6, 2016 | Not classified | Dallas District Office | |
| February 1, 2011 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Gotera, Inc. dba Mama Lycha Foods, Inc.
- FDA Inspection 1234312 - 2024-09-06
- FDA Inspection 1179910 - 2022-09-12
- FDA Inspection 1028035 - 2017-09-28
- FDA Inspection 994221 - 2016-12-06
- FDA Inspection 710143 - 2011-02-01
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