# FDA 483 - SK Biotek Co., Ltd. (Sejong Plant) - June 10, 2026

Source: https://www.keypedia.com/records/483/sk-biotek-co-ltd-sejong-plant/682aacdb-d865-421f-9fb4-42316bd9d06f

> FDA 483 for SK Biotek Co., Ltd. (Sejong Plant) on June 10, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SK Biotek Co., Ltd. (Sejong Plant)
- Inspection Date: 2026-06-10
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of SK Biotek Co., Ltd.'s Sejong Plant, an API manufacturer, revealed two significant observations. The firm lacked adequate scientific justification for its reduced microbial enumeration testing program for API batches. Additionally, established hold times for raw materials, intermediates, and finished APIs were not properly documented and verified in batch records.

## Related Officers

- [Consumer Safety Officer , Investigator](https://www.keypedia.com/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)

Company: https://www.keypedia.com/companies/sk-biotek-co-ltd-sejong-plant/22f4465e-20a8-43d1-9c64-52eacad2d9e4

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8