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

Mar 11, 2026

CGMP/Finished Pharmaceuticals/Adulterated

Read the letter on FDA.gov ›

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)

Nov 25, 2019 Class II

Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.

Terminated

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number

3001237145

Address

18685 East Plaza Drive, Parker, Colorado

Establishment type

Drug establishment

Products / operations

Analytical testing, Labeling, Manufacturing

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Oct 2, 2025 · Official Action Indicated (OAI)
Jan 10, 2020 · Voluntary Action Indicated (VAI)
May 28, 2019 · 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)

Form 483 observations

Oct 2, 2025, 6 observations: Absence of Written Procedures; Control procedures to monitor and validate performance; Cleaning / Sanitizing / Maintenance
Jan 10, 2020, 6 observations: Scientifically sound laboratory controls; Written procedures not established/followed; Buildings not maintained in good state of repair
May 28, 2019, 2 observations: Design control - no procedures; Lack of Written MDR Procedures
Dec 18, 2015, 4 observations: Scientifically sound laboratory controls; Investigations of discrepancies, failures; Sampling and testing plans not followed
Nov 23, 2011, 2 observations: Review of representative number of batches; Equipment construction - reactive surfaces
Aug 11, 2010, 11 observations: GMP Training Frequency; Following/documenting laboratory controls; Investigations of discrepancies, failures

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.

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Source: FDA public data · status as of 2026-06-06