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# CGMP Violations at Woorilife & Health
- URL: https://www.fdaweb.com/cgmp-violations-at-woorilife-health/
- Published: 2024-01-10T12:00:00.000Z
- Updated: 2026-09-14T14:20:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156107

FDA says its review of records submitted by South Korea’s Woorilife & Health, registered with the agency as a manufacturer of over-the-counter drugs, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 12/28/2023 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/woorilife-health-672936-12282023?ref=fdaweb.com) says the specific violations were:

- failing to conduct at least one test to verify the identity of each component of a drug product; and
- failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

FDA says that based on the nature of the violations identified at the firm, it should engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements if it intends to resume manufacturing drugs for the U.S. market. The agency placed Woorilife on a 12/27/2023 import alert.

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