Company
United StatesPristine Bay LLC, Blue Ash, OH – FDA Inspections
Inspection records and compliance data for Pristine Bay LLC in Blue Ash, Ohio. 8 FDA inspections on record (2 OAI), 1 Form 483, 1 warning letter, last inspected August 22, 2025.
Company Profile
This profile covers Pristine Bay LLC based in Blue Ash, Ohio, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 2
- VAI
- 4
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 1
First inspected July 20, 2010. Last inspected August 22, 2025.
Most cited issue areas
- No AE report made (dietary supplement)3 inspections
- Quality control - quality, dietary supplement3 inspections
- Specifications - identity, purity, strength, composition3 inspections
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 22, 2025 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling, and Economics | 1279202 |
| June 29, 2018 | NAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1062341 |
| May 19, 2015 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 928262 |
| April 16, 2014 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 875344 |
| February 26, 2014 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 867773 |
| December 17, 2012 | OAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 810992 |
| September 17, 2012 | OAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 799177 |
| July 20, 2010 | NAI | Foods & Cosmetics · Foodborne Biological Hazards | 685051 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Pristine Bay LLC
FEI Number
3004476935
Address
11260 Cornell Park Dr, Blue Ash, Ohio 45242, United States
Country
United States
ID: 8b3671ea-60a6-4a79-90b7-bfea75431747