OraLabs, Inc
FDA inspection history in Parker, Colorado, 2015 to 2026
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2015: one Form 483; 2020: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Parker, Colorado.
- 2020One Form 483, at Parker, Colorado.
- 2020The longest 483 on file: 6 observations over 5 pages at Parker, Colorado.
- 2026One warning letter, at Parker, Colorado.
Cited most
Across all OraLabs observations on file
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.165(c)Testing and release for distribution1
- 21 CFR 211.182Equipment cleaning and use log1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete OraLabs file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Parker, Colorado
Two Form 483s and one warning letter · 2015 to 2026 · 10 observations
Latest: Warning letter, Mar 11, 2026 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-11 | Warning letter Warning letter | Parker, Colorado | — | $99 |
| 2020-01-10 | 483 Form 483 | Parker, Colorado | 6 | $99 |
| 2015-12-18 | 483 Form 483 | Parker, Colorado | 4 | $99 |
Investigators on these documents
FEI number 3001237145 · most recent document Mar 11, 2026
About OraLabs, Inc
How many FDA Form 483s has OraLabs, Inc received?
FDA Intel has 2 Form 483s on file for OraLabs, Inc; the most recent is dated Jan 10, 2020.
When was OraLabs, Inc last inspected by FDA?
The most recent FDA inspection document on file for OraLabs, Inc is a Form 483 dated Jan 10, 2020, for the site in Parker, Colorado.
What did FDA cite at OraLabs, Inc?
The regulations cited most in the observations on file for OraLabs, Inc are 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.165(c) (Testing and release for distribution), 1 time; 21 CFR 211.182 (Equipment cleaning and use log), 1 time.
Has OraLabs, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for OraLabs, Inc; the most recent is dated Mar 11, 2026.