FDA Inspection
Threshold Enterprises LtdThreshold Enterprises Ltd – FDA Inspection, Apr 25, 2017
Record Details
This FDA Inspection record concerns Threshold Enterprises Ltd, with an inspection on April 25, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 1c1f8952-a545-4ac5-8fda-b3be835be136
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1010805
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.503Written procedures - returned dietary supplement; destroyed
- 21 CFR 111.535(a)Records - returned dietary supplement: readily available
- 21 CFR 111.475(b)(2)Records - product distribution
- 21 CFR 111.70(c)(2)Specifications identity, purity strength, composition
- 21 CFR 111.320(a)Examination, testing; appropriate
- 21 CFR 111.105(i)QC - required operations master manufacturing/batch records
- 21 CFR 111.77(a)Specifications not met - reject, quality control
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Other FDA inspections of Threshold Enterprises Ltd
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2026 | Not classified | San Francisco District Office | Food Composition, Standards, Labeling and Econ |
| August 27, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 20, 2016 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 3, 2013 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 14, 2011 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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