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# 5 CGMP Issues Cited in Ross Healthcare Inspection
- URL: https://www.fdaweb.com/5-cgmp-issues-cited-in-ross-healthcare-inspection/
- Published: 2026-02-25T12:00:00.000Z
- Updated: 2026-09-14T13:34:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160724

A 7/30-8/12/2025 FDA inspection at the AQ USA drug manufacturing facility in Lynden, WA, doing business as Ross Healthcare, identified five significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/12 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aq-usa-inc-dba-ross-healthcare-inc-719517-02122026?ref=fdaweb.com) notes that the company operates a drug manufacturing facility in Canada that was placed on an 11/30/2017 Import Alert due to significant CGMP violations, and evidence obtained during the inspection demonstrated that Ross is manufacturing the same product line at the Lynden facility that was previously produced in Canada.

The specific CGMP violations cited in the Lynden inspection were:

- failure to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms, and 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, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
- failure to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures;
- failure to conduct at least one test to verify the identity of each component of a drug product and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
- failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use the results of stability testing to determine appropriate storage conditions and expiration dates; and
- failure of the firm’s quality control unit to exercise its responsibility to ensure that manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

FDA recommends that Ross engage a qualified consultant to assist it in meeting CGMP requirements. The agency told the company to correct violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.