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

Source: https://www.keypedia.com/records/483/lcc-ltd/83f35879-1111-4f8b-911a-198f972b060a

> 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 Partnerships
- Summary: LCC Ltd., an OTC drug manufacturer in Eumseong, Korea, was cited for numerous significant deficiencies during an FDA inspection from March 18-22, 2024. The observations highlight severe issues across quality control, data integrity, personnel training, equipment management, and record-keeping, indicating a fundamental lack of adherence to cGMP. The firm demonstrated a pervasive failure to ensure the identity, strength, quality, and purity of its drug products.

## Related Documents

- [WARNING_LETTER - 2023-08-03](https://www.keypedia.com/records/warning_letter/lcc-ltd/5d30922e-f3cc-4c58-91c4-d69b43d37e87)
- [483 - 2024-03-22](https://www.keypedia.com/records/483/lcc-ltd/44c93a34-0fa7-4938-a170-66660546a92e)
- [483 - 2024-03-18](https://www.keypedia.com/records/483/lcc-ltd/211e095f-4deb-41f6-aa40-9639951207c2)
- [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-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3