Drug establishmentActive, Registered FY2026FDA warning letter on file
OraLabs, Inc
OraLabs, Inc is an FDA-registered drug establishment (FEI 3001237145) located in Parker, Colorado. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2025-10-02) was classified OAI. FDA has issued 1 warning letter(s) to this facility.
FDA warning letter
A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.
Recalls (1)
Recall data from openFDA enforcement reports (FDA Recall Enterprise System).
Establishment record
Inspection history
Jan 10, 2020 · Voluntary Action Indicated (VAI)
May 28, 2019 · Voluntary Action Indicated (VAI)
Jul 13, 2018 · Voluntary Action Indicated (VAI)
Dec 18, 2015 · Voluntary Action Indicated (VAI)
Jun 26, 2013 · No Action Indicated (NAI)
Nov 23, 2011 · Voluntary Action Indicated (VAI)
Aug 11, 2010 · Official Action Indicated (OAI)
Jan 10, 2020, 6 observations: Scientifically sound laboratory controls; Procedures not in writing, fully followed; Written procedures not established/followed
May 28, 2019, 2 observations: Lack of Written MDR Procedures; Design control - no procedures
Dec 18, 2015, 4 observations: Sampling and testing plans not followed; Scientifically sound laboratory controls; Investigations of discrepancies, failures
Nov 23, 2011, 2 observations: Review of representative number of batches; Equipment construction - reactive surfaces
Aug 11, 2010, 11 observations: Investigations of discrepancies, failures; Changes to Procedures Not Reviewed, Approved; Theoretical Yield and Percentages
FDA record timeline
Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.
Questions
Is OraLabs, Inc registered with the FDA?
Yes. OraLabs, Inc is an FDA-registered drug establishment (FEI 3001237145) in Parker, Colorado. Its current registration status is Active, Registered FY2026.
Has OraLabs, Inc received an FDA warning letter?
Yes. FDA issued a warning letter to OraLabs, Inc; the most recent is dated Mar 11, 2026 (CGMP/Finished Pharmaceuticals/Adulterated).
What does OraLabs, Inc do?
OraLabs, Inc's FDA-registered operations are: Analytical testing, Labeling, Manufacturing.
Related facilities
Source: FDA public data · status as of 2026-08-22