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# FDA Warns Westwood Labs on CGMP Violations
- URL: https://www.fdaweb.com/fda-warns-westwood-labs-on-cgmp-violations/
- Published: 2024-05-14T12:00:00.000Z
- Updated: 2026-09-14T14:30:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156977

A 10/30-11/20/2023 FDA inspection at Westwood Laboratories in Azusa, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/17 Warning [Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/westwood-laboratories-llc-674728-04172024?ref=fdaweb.com) says the four specific violations were:

- failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
- failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
- failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess.

The letter says Westwood’s quality system is inadequate and recommends that it retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

FDA told the company to correct violations promptly and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.