# FDA 483 - Kolmar Korea Co., Ltd. - Gwanjeong Factory - February 16, 2024

Source: https://www.keypedia.com/records/483/kolmar-korea-co-ltd-gwanjeong-factory/e92f5c2e-df6a-4051-a103-7b8421a73131

> FDA 483 for Kolmar Korea Co., Ltd. - Gwanjeong Factory on February 16, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kolmar Korea Co., Ltd. - Gwanjeong Factory
- Inspection Date: 2024-02-16
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Kolmar Korea Co., Ltd. - Gwanjeong Factory in Chungcheongnam-Do, Korea, received a Form FDA 483 with six observations during an inspection from February 8-16, 2024. The inspection revealed significant deficiencies in quality control, batch record documentation, data integrity, product traceability, and raw material warehousing for OTC drug products shipped to the US market. These issues indicate a lack of robust quality systems and adherence to good manufacturing practices.

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## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

Company: https://www.keypedia.com/companies/kolmar-korea-co-ltd-gwanjeong-factory/392855b3-652a-43a6-abb2-d78b2b634c5e

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3