Drug establishmentActive, Registered FY2026FDA warning letter on file

Westwood Laboratories, LLC.

Westwood Laboratories, LLC. is an FDA-registered drug establishment (FEI 2020372) located in Azusa, California. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2024-10-31) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Apr 17, 2024

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.

Establishment record

FEI Number

2020372

Address

710 South Ayon Avenue, Azusa, California

Establishment type

Drug establishment

Products / operations

Active pharmaceutical ingredient (API) manufacturing, Labeling, Manufacturing, Packaging, Relabeling, Repackaging

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Oct 31, 2024 · Official Action Indicated (OAI)
Oct 31, 2024 · Official Action Indicated (OAI)
Nov 20, 2023 · Official Action Indicated (OAI)
Nov 20, 2023 · Official Action Indicated (OAI)
Apr 5, 2022 · Voluntary Action Indicated (VAI)
Apr 5, 2022 · Voluntary Action Indicated (VAI)
Aug 2, 2019 · No Action Indicated (NAI)
Aug 2, 2019 · Voluntary Action Indicated (VAI)
May 30, 2019 · Voluntary Action Indicated (VAI)
May 30, 2019 · Voluntary Action Indicated (VAI)
Jan 30, 2019 · No Action Indicated (NAI)
Feb 5, 2016 · Voluntary Action Indicated (VAI)

Form 483 observations

Oct 31, 2024, 6 observations: Absence of Written Procedures; Lack of written stability program; Identity Testing of Each Component
Nov 20, 2023, 7 observations: Identity Testing of Each Component; Lack of written stability program; Scientifically sound laboratory controls
Apr 5, 2022, 4 observations: Prepared for each batch, include complete information; Changes to Procedures Not Reviewed, Approved; Computer control of master formula records
Aug 2, 2019, 5 observations: Environmental control Lack of or inadequate procedures; DHR content; Equipment Installation, Placement, Specified Requirements
May 30, 2019, 3 observations: Procedures for non-sterile drug products; Computer control of master formula records; Lab controls established, including changes
Feb 5, 2016, 4 observations: Lab controls established, including changes; Changes to Procedures Not Reviewed, Approved; SOPs not followed / documented

Questions

Is Westwood Laboratories, LLC. registered with the FDA?

Yes. Westwood Laboratories, LLC. is an FDA-registered drug establishment (FEI 2020372) in Azusa, California. Its current registration status is Active, Registered FY2026.

Has Westwood Laboratories, LLC. received an FDA warning letter?

Yes. FDA issued a warning letter to Westwood Laboratories, LLC.; the most recent is dated Apr 17, 2024 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Westwood Laboratories, LLC. do?

Westwood Laboratories, LLC.'s FDA-registered operations are: Active pharmaceutical ingredient (API) manufacturing, Labeling, Manufacturing, Packaging, Relabeling, Repackaging.

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