# FDA 483 - Kolmar Korea Co., Ltd. - Gwanjeong Factory - July 07, 2022

Source: https://www.keypedia.com/records/483/kolmar-korea-co-ltd-gwanjeong-factory/2882c132-4908-40e2-985a-7c40e45ea5bd

> FDA 483 for Kolmar Korea Co., Ltd. - Gwanjeong Factory on July 07, 2022. 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: 2022-07-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Kolmar Korea Co., Ltd. - Gwanjeong Factory in Chungcheongnam-Do, Korea, revealed a significant issue regarding the stability testing of OTC drug products. The firm failed to adequately test batches to determine appropriate expiration dates, specifically by not conducting ongoing stability studies after initial testing. This indicates a lapse in quality control practices for drug product shelf-life determination.

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## Related Officers

- [Pharmaceutical investigator](https://www.keypedia.com/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)

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