# FDA 483 - FirstCham Co., Ltd. - October 27, 2023

Source: https://www.globalkeysolutions.net/records/483/firstcham-co-ltd/6edc9f33-6f76-4e6b-961c-6354a559d7d8

> FDA 483 for FirstCham Co., Ltd. on October 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FirstCham Co., Ltd.
- Inspection Date: 2023-10-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: First Cham Co., Ltd., a drug and cosmetic manufacturer in Eumseong, Korea, was inspected by the FDA from October 23-27, 2023. The inspection revealed significant deficiencies across quality control, data integrity, validation, and manufacturing processes, including the distribution of out-of-specification drug products. These findings indicate a lack of adherence to cGMP requirements, posing potential risks to drug product quality and patient safety.

## Related Documents

- [483 - 2023-10-27](https://www.globalkeysolutions.net/records/483/firstcham-co-ltd/268fd2d7-b782-459f-8dbf-c2d2183092ea)
- [WARNING_LETTER - 2023-10-27](https://www.globalkeysolutions.net/records/warning_letter/firstcham-co-ltd/09618ff9-ad25-44f5-932d-4c1d28b0cbb9)

## Related Officers

- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.globalkeysolutions.net/companies/firstcham-co-ltd/75e684a5-8f1e-4cd7-b67c-10ffed3d26f0

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