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# Repeat CGMP Violations at Kirkman Drug Manufacturing
- URL: https://www.fdaweb.com/repeat-cgmp-violations-at-kirkman-drug-manufacturing/
- Published: 2026-02-03T12:00:00.000Z
- Updated: 2026-09-14T15:32:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160594

An 8/18-8/22/2025 FDA inspection at the HTO Nevada drug manufacturing facility doing business as Kirkman in Lake Oswego, OR, found repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/27 [Warning Letter](ttps://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hto-nevada-inc-dba-kirkman-719074-01272026) says the specific violations were:

- 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;
- 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; and
- failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products.

The letter says that similar CGMP observations were made in a 3/19/2019 inspection, and Kirkman proposed specific remediation in its response. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA says.

The agency recommends that Kirkman engage a qualified consultant to evaluate its operations and assist it in evaluating products that remain in distribution. It acknowledges the company’s commitment to cease production of all drugs at the facility for the U.S. market and asks for clarification on whether Kirkman intends to resume production in the future.

The company was told to address violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent them from recurring, with a schedule for completing the corrections.