# FDA 483 - Kolmask Co., Ltd. - September 27, 2024

Source: https://www.globalkeysolutions.net/records/483/kolmask-co-ltd/909248da-72d9-4656-84f7-f7a431ea16cf

> FDA 483 for Kolmask Co., Ltd. on September 27, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Kolmask Co., Ltd.
- Inspection Date: 2024-09-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Kolmask Co., Ltd. in Namdong-gu Incheon, South Korea, was inspected by the FDA, resulting in four observations. The inspection revealed deficiencies in cleaning and maintenance procedures, lack of validation for microbial test methods, issues with representative sampling of drug products, and incomplete master production and control records for water usage. These findings indicate potential concerns regarding the quality and control of OTC drug product manufacturing.

## Related Officers

- [Team Biologics Staff](https://www.globalkeysolutions.net/people/linda-thai/f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8)

Company: https://www.globalkeysolutions.net/companies/kolmask-co-ltd/3b0217a7-901b-40b4-a673-74b3d7b169ad

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