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

Source: https://www.keypedia.com/records/483/hanbul-cosmetics-co-ltd/7f52b464-4e58-461f-97aa-de3301615e5f

> 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: Center for Drug Evaluation and Research
- Summary: During an FDA inspection from November 27 to December 1, 2017, It's Hanbul Co., Ltd., an Over-The-Counter (OTC) drug manufacturer in Eumseong-gun, Korea, received a Form FDA 483 highlighting fourteen significant observations related to its compliance with Current Good Manufacturing Practices (cGMP). Key issues included incomplete and inaccurate batch production and control records, lacking essential manufacturing details, cleaning verification, and operator/second-person verifications. The firm also had deficient equipment cleaning procedures and validation, and failed to provide evidence of microbiological testing or a written stability testing program to support product expiry. Further observations noted the absence of Installation, Operation, and Performance Qualifications (IQ/OQ/PQ) for critical production, packaging, and laboratory equipment. Computer systems for laboratory instruments lacked proper controls to prevent data modification and audit trails were not enabled. Instrument calibration was not performed, and quality control unit responsibilities, including change control and test review, were inadequate. The company also lacked procedures to prevent microbial contamination during testing, and had insufficient segregation and identification of raw materials and finished products. Additionally, employees had not received adequate cGMP training, and analytical instrument use logs were not maintained. It's Hanbul Co., Ltd. must address these deficiencies to ensure full compliance with regulatory standards for OTC drug manufacturing.

## Related Documents

- [483 - 2017-12-01](https://www.keypedia.com/records/483/hanbul-cosmetics-co-ltd/25769b6c-b831-45a0-9210-ce5450efd24e)
- [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)
- [Manager](https://www.keypedia.com/people/cheol-hee-jeong/db22158c-b9dc-48b8-adb4-58475a2469b8)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c