FDA Inspection
Llorens Pharmaceuticals International Division, Inc.Llorens Pharmaceuticals International Division, Inc. – FDA Inspection, Sep 26, 2025
Record Details
This FDA Inspection record concerns Llorens Pharmaceuticals International Division, Inc., with an inspection on September 26, 2025, issued by the Florida District Office, covering foods & cosmetics.
- Inspection Date
- September 26, 2025
- Product Type
- Foods & Cosmetics
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ID · 969425ff-23d7-441f-9438-b33b2eeb89d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1229574
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling, and Economics
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.315(a)Criteria for establishing specifications
- 21 CFR 111.315(d)Standard reference materials; criteria for selecting
- 21 CFR 111.70(e)Specifications - finished dietary supplement
- 21 CFR 111.210Master manufacturing record - record requirements
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Other FDA inspections of Llorens Pharmaceuticals International Division, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2025 | VAI | Florida District Office | Drug Quality Assurance |
| March 11, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 29, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 12, 2016 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 22, 2012 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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