# FDA 483 - Hankook Cosmetics Manufacturing Co., Ltd - November 21, 2024

Source: https://www.keypedia.com/records/483/hankook-cosmetics-manufacturing-co-ltd/04056849-b385-49b9-93f2-1af8bca62c2a

> FDA 483 for Hankook Cosmetics Manufacturing Co., Ltd on November 21, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hankook Cosmetics Manufacturing Co., Ltd
- Inspection Date: 2024-11-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Hankook Cosmetics Manufacturing Co., Ltd in Eumseong-gun, Korea, an OTC drug product manufacturer, revealed significant deficiencies in their quality systems. Observations included a lack of completed stability studies to support expiration dates, incomplete laboratory records, and inadequate written procedures for quality control, sampling, and equipment cleaning. These findings indicate a broad failure to adhere to good manufacturing practices.

## Related Documents

- [483 - 2024-11-21](https://www.keypedia.com/records/483/hankook-cosmetics-manufacturing-co-ltd/64f4c0ae-4bed-4e6d-bcfa-de0983fe6054)

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)

Company: https://www.keypedia.com/companies/hankook-cosmetics-manufacturing-co-ltd/bad91ffc-3949-43ef-a17a-592af478eebd

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8