FDA Inspection
Cape Fear Naturals, LLCCape Fear Naturals, LLC – FDA Inspection, Apr 11, 2019
Record Details
This FDA Inspection record concerns Cape Fear Naturals, LLC, with an inspection on April 11, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · fcef7c2d-dc22-4c21-b3c1-1a4e60d0c53f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1085921
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.127Quality control operations - packaging, labeling
- 21 CFR 111.430(b)Records - packaging, labeling operations
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
- 21 CFR 111.503Written procedures returned dietary supplement; reprocessing
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
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Other FDA inspections of Cape Fear Naturals, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 3, 2025 | Not classified | Atlanta District Office | |
| May 4, 2022 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| April 13, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 15, 2016 | OAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Cape Fear Naturals, LLC
- FDA Inspection 1294784 - 2025-12-03
- FDA Inspection 1169255 - 2022-05-04
- FDA Inspection 1048187 - 2018-04-13
- FDA Inspection 986253 - 2016-09-15
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