FDA Inspection
Sportron International, IncSportron International, Inc – FDA Inspection, Mar 27, 2019
Record Details
This FDA Inspection record concerns Sportron International, Inc, with an inspection on March 27, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 9fae2fe5-e7d1-4bc1-898a-a519b1aa3f8e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1084109
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 111.12(c)Personnel - education, training, experience
- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.403Written procedures - labeling operations
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.70(e)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
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Other FDA inspections of Sportron International, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2020 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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