Company
United StatesOraLabs LLC, Parker, CO – FDA Inspections
Inspection records and compliance data for OraLabs LLC in Parker, Colorado. 9 FDA inspections on record (2 OAI), 3 Form 483s, last inspected August 21, 2026.
Company Profile
This profile covers OraLabs LLC based in Parker, Colorado, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 2
- VAI
- 5
- NAI
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected August 11, 2010. Last inspected August 21, 2026.
Most cited issue areas
- Investigations of discrepancies, failures3 inspections
- Control procedures to monitor and validate performance2 inspections
- Following/documenting laboratory controls2 inspections
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 21, 2026 | NAI | Foods & Cosmetics · Colors and Cosmetics Technology | 1333886 |
| October 2, 2025 | OAI | Human Drugs · Drug Quality Assurance | 1284290 |
| January 10, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1114784 |
| May 28, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1090928 |
| July 13, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1061733 |
| December 18, 2015 | VAI | Human Drugs · Drug Quality Assurance | 967035 |
| June 26, 2013 | NAI | Human Drugs · Drug Quality Assurance | 837917 |
| November 23, 2011 | VAI | Human Drugs · Drug Quality Assurance | 756796 |
| August 11, 2010 | OAI | Human Drugs · Drug Quality Assurance | 678668 |
FDA documents
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Company Information
Name
OraLabs LLC
FEI Number
3001237145
Address
18685 Plaza Dr, Parker, Colorado 80134, United States
Country
United States
ID: 41e1dfcc-51f3-408c-984a-a59d0985d971