FDA Inspection
Pristine Bay LLCPristine Bay LLC – FDA Inspection, Feb 26, 2014
Record Details
This FDA Inspection record concerns Pristine Bay LLC, with an inspection on February 26, 2014, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Pristine Bay LLC
- Inspection Date
- February 26, 2014
- Product Type
- Food/cosmetics
View Company Profile
ID · 43528b18-9220-4fbb-8ae4-cd24e4a9dd52
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 867773
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
17- 21 CFR 111.560(a)(1)Product complaint - quality control review
- No AE report made (dietary supplement)
- 21 CFR 111.570(b)(2)(ii)(F)Record - product complaint; findings
- 21 CFR 111.570(b)(2)(ii)(D)Record - product complaint; nature, how used
- 21 CFR 111.570(b)(2)(ii)(E)Record - product complaint; reply
- 21 CFR 111.530Returned dietary supplement - investigation
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.503Written procedures - returned dietary supplement; salvaged
- 21 CFR 111.455(a)Hold - temperature, humidity, light
- 21 CFR 111.65Quality control - quality, dietary supplement
Showing 10 of 17 citations.
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Other FDA inspections of Pristine Bay LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2025 | VAI | Cincinnati District Office | Food Composition, Standards, Labeling, and Economics |
| June 29, 2018 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 19, 2015 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 16, 2014 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| December 17, 2012 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Pristine Bay LLC
- FDA Inspection 1279202 - 2025-08-22
- FDA Inspection 1062341 - 2018-06-29
- FDA Inspection 928262 - 2015-05-19
- FDA Inspection 875344 - 2014-04-16
- FDA Inspection 810992 - 2012-12-17
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