# FDA 483 - Kolmar Korea Co. Ltd. - July 05, 2019

Source: https://www.globalkeysolutions.net/records/483/kolmar-korea-co-ltd/0c055ad2-35dd-41b2-8097-94af2af70516

> FDA 483 for Kolmar Korea Co. Ltd. on July 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kolmar Korea Co. Ltd.
- Inspection Date: 2019-07-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Kolmar Korea Co. Ltd., an OTC drug manufacturer in Sejong-si, Korea, received a Form 483 with seven observations during an FDA inspection. The inspection revealed severe deficiencies in quality control unit oversight, data integrity, record-keeping practices, complaint investigations, and employee training. These issues indicate a systemic failure to adhere to cGMP regulations, with several observations being repeats from previous inspections.

## Related Documents

- [483 - 2017-09-28](https://www.globalkeysolutions.net/records/483/kolmar-korea-co-ltd/4f9f7dcf-0d54-4666-8711-6a7c9f087cc4)
- [WARNING_LETTER - 2017-09-28](https://www.globalkeysolutions.net/records/warning_letter/kolmar-korea-co-ltd/8aeba44d-2fa4-40b3-8f5a-288ca14d2853)

## Related Officers

- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.globalkeysolutions.net/companies/kolmar-korea-co-ltd/1593ea1f-ab89-4e5c-852b-2ccd0ce714af

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