# FDA 483 - LCC Ltd. - March 22, 2024

Source: https://www.keypedia.com/records/483/lcc-ltd/44c93a34-0fa7-4938-a170-66660546a92e

> FDA 483 for LCC Ltd. on March 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LCC Ltd.
- Inspection Date: 2024-03-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: LCC Ltd., an OTC drug manufacturer in Eumseong, Korea, received 11 observations during an FDA inspection, highlighting severe deficiencies across its quality control unit, laboratory controls, and manufacturing processes. The firm failed to maintain raw data, conduct adequate stability studies, and provide requested records, indicating a fundamental lack of cGMP understanding among personnel. These issues collectively demonstrate a significant breakdown in ensuring drug product quality and safety.

## Related Documents

- [WARNING_LETTER - 2023-08-03](https://www.keypedia.com/records/warning_letter/lcc-ltd/5d30922e-f3cc-4c58-91c4-d69b43d37e87)
- [WARNING_LETTER - 2024-03-22](https://www.keypedia.com/records/warning_letter/lcc-ltd/5858f6f9-63bf-4e2c-a2ac-4d9f87e9b032)

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)
- [Medical Officer at FDA](https://www.keypedia.com/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)

Company: https://www.keypedia.com/companies/lcc-ltd/a5df9151-8e49-433d-b92a-fc3e5dbebd50

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1