# FDA 483 - Hanbul Cosmetics Co., Ltd - December 01, 2017

Source: https://www.keypedia.com/records/483/hanbul-cosmetics-co-ltd/25769b6c-b831-45a0-9210-ce5450efd24e

> FDA 483 for Hanbul Cosmetics Co., Ltd on December 01, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hanbul Cosmetics Co., Ltd
- Inspection Date: 2017-12-01
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: It's Hanbul Co., Ltd. in Eumseong-gun, Chungcheongbuk-do, Korea, an OTC drug manufacturer, was inspected by the FDA from 11/27/17 to 12/01/17. The inspection revealed significant deficiencies across multiple areas of good manufacturing practices, including incomplete batch records, inadequate cleaning validation, lack of microbiological testing data, absent stability programs, and poor control over computer systems and equipment calibration. These findings indicate a broad lack of adherence to regulatory requirements for drug product quality and control.

## Related Documents

- [483 - 2017-12-01](https://www.keypedia.com/records/483/hanbul-cosmetics-co-ltd/7f52b464-4e58-461f-97aa-de3301615e5f)
- [WARNING_LETTER - 2017-12-01](https://www.keypedia.com/records/warning_letter/hanbul-cosmetics-co-ltd/5088c060-b26c-44cb-a892-ce2347a227d8)

## Related Officers

- [Christopher S. Keating](https://www.keypedia.com/people/christopher-s-keating/94fcfd32-feb5-4b6c-80da-16202f4be01d)

Company: https://www.keypedia.com/companies/hanbul-cosmetics-co-ltd/085a6ccb-5044-45f6-b365-b048cb696073

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd