FDA Inspection
American Natural Products, Inc.American Natural Products, Inc. – FDA Inspection, Oct 2, 2017
Record Details
This FDA Inspection record concerns American Natural Products, Inc., with an inspection on October 2, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Person
- Omayra N. Rodriguez-Ruiz (Issuing Officer)
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ID · ba383f20-81f7-4b45-87ac-3325838811e8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1027359
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.75(a)(2)Component - confirm identity; specifications met
- 21 CFR 111.70(a)Specifications - manufacturing process
- 21 CFR 111.70(g)Specifications - finished packaging, labeling
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.105(a)Quality control - processes, specifications, written procedures
- 21 CFR 111.105Quality control - ensure quality; package, labeled, master record
- 21 CFR 111.75(c)(4)Documentation - specifications met; basis, quality control
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Other FDA inspections of American Natural Products, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2025 | VAI | Florida District Office | Food Composition, Standards, Labeling, and Economics |
| May 10, 2022 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 28, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| November 8, 2013 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 20, 2012 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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