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# CGMP Violations at S. Korea’s ReBom Co.
- URL: https://www.fdaweb.com/cgmp-violations-at-s-koreas-rebom-co/
- Published: 2024-07-09T12:00:00.000Z
- Updated: 2026-09-14T14:34:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157304

FDA’s review of records supplied at its request by ReBom Co., Ltd., a Sejong, South Korea, manufacturer of over-the-counter drug products, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/26 Warning Letter says the specific violations were:

- failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products; and
- failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality.

The letter says that based on the records and information the company provided, ReBom did not demonstrate that it conducted adequate finished drug product testing. Based on the nature of the violations it identified, FDA recommends that ReBom retain a qualified consultant to audit its entire operation and assist it in meeting CGMP requirements.

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