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# Multiple Violations at S. Korea’s LCC Ltd.
- URL: https://www.fdaweb.com/multiple-violations-at-s-koreas-lcc-ltd/
- Published: 2024-12-03T12:00:00.000Z
- Updated: 2026-09-14T14:48:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158290

A 3/18-3/22 FDA inspection at the LCC Ltd. drug manufacturing facility in Chungcheongbuk-do, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations and unapproved new drug violations. An 11/21 [Warning Letter](ttps://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lcc-ltd-688576-11212024) says specific CGMP violations were:

- 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 of the quality control unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity; and
- failure to ensure that laboratory records include complete data derived from all tests necessary to ensure compliance with established specifications and standards.

The letter says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the effectiveness and quality of the manufactured drugs. It recommends that LCC use an independent third-party consultant to audit its operation, perform data integrity training, and assist the company in meeting FDA data integrity requirements.

FDA says two of the company’s over-the-counter mouthwash products are legally considered to be drugs. They are not considered to be GRASE (generally recognized as safe and effective) because they do not comply with the appropriate over-the-counter monograph. Because there is no approved application in effect for the products, FDA says, they are considered to be unapproved new drugs that are being illegally marketed. The products also are considered to be misbranded, it says.

The company was placed on an import alert on 5/3/2023 because the information it provided in response to an FDA records request did not appear to conform to CGMP. It remains under that alert, FDA says.

The letter notes that an 8/3/2023 Warning Letter cited similar significant CGMP violations and the company proposed specific remediation for the violations. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA says.

The letter acknowledges that LCC ceased regulated drug manufacturing operations and cautions that if it intends to resume drug manufacturing it should engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

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