FDA Inspection
Cape Fear Naturals, LLCCape Fear Naturals, LLC – FDA Inspection, Apr 13, 2018
Record Details
This FDA Inspection record concerns Cape Fear Naturals, LLC, with an inspection on April 13, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f8733dc2-3666-41c4-9716-e6a4f7b1004b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048187
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.430(b)Records - packaging, labeling operations
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.503Written procedures returned dietary supplement; reprocessing
- 21 CFR 111.127Quality control operations - packaging, labeling
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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 11, 2019 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| 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 1085921 - 2019-04-11
- FDA Inspection 986253 - 2016-09-15
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