Drug establishmentActive, Registered FY2026FDA warning letter on file

Sanitor Corporation

Sanitor Corporation is an FDA-registered drug establishment (FEI 3005871025) located in Stanton, California. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2026-03-23) was classified NAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Nov 29, 2021

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)

Sep 21, 2021 Class II

CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.

Terminated

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

Establishment record

FEI Number

3005871025

Address

8400 Cerritos Ave, Stanton, California

Establishment type

Drug establishment

Products / operations

Manufacturing

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Mar 23, 2026 · No Action Indicated (NAI)
Aug 20, 2024 · No Action Indicated (NAI)
May 10, 2024 · Voluntary Action Indicated (VAI)
Apr 14, 2023 · Official Action Indicated (OAI)
Jun 3, 2021 · Official Action Indicated (OAI)
Jun 3, 2021 · Official Action Indicated (OAI)
Apr 28, 2016 · Voluntary Action Indicated (VAI)
Aug 15, 2013 · Voluntary Action Indicated (VAI)
Nov 15, 2011 · Voluntary Action Indicated (VAI)
Aug 5, 2010 · Voluntary Action Indicated (VAI)

Form 483 observations

May 10, 2024, 2 observations: Results not used for expiration dates, storage cond.; Investigations of discrepancies, failures
Apr 14, 2023, 5 observations: Training--operations, GMPs, written procedures; Equipment for Environmental Control; Computer control of master formula records
Jun 3, 2021, 13 observations: Procedures not in writing, fully followed; Computer control of master formula records; Quality control unit review of records
Apr 28, 2016, 2 observations: Components withheld from use pending release; Individual inventory record
Aug 15, 2013, 3 observations: Deviations from laboratory control requirements; Written record of investigation incomplete; Investigations of discrepancies, failures
Nov 15, 2011, 1 observation: Lab controls established, including changes

Questions

Is Sanitor Corporation registered with the FDA?

Yes. Sanitor Corporation is an FDA-registered drug establishment (FEI 3005871025) in Stanton, California. Its current registration status is Active, Registered FY2026.

Has Sanitor Corporation received an FDA warning letter?

Yes. FDA issued a warning letter to Sanitor Corporation; the most recent is dated Nov 29, 2021 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Sanitor Corporation do?

Sanitor Corporation's FDA-registered operations are: Manufacturing.

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