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

Source: https://www.keypedia.com/records/483/kolmar-korea-co-ltd-gwanjeong-factory/da79f50f-27f4-4cd8-ba09-eecb69968c47

> 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 Biological Products Operations - Division I
- Summary: Kolmar Korea Co., Ltd. - Gwanjeong Factory, a drug manufacturer in Sejong-Si, Korea, was cited for multiple significant deficiencies during an FDA inspection from February 8-16, 2024. The observations highlight severe issues across quality control, production record-keeping, data integrity, and raw material warehousing, indicating a lack of robust controls for OTC drug manufacturing. These deficiencies include inadequate microbial testing, missing batch record documentation, insecure computerized lab systems, and a failure to establish impurity specifications.

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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-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1