# FDA 483 - YB CHEMIA LLC - October 24, 2024

Source: https://www.keypedia.com/records/483/yb-chemia-llc/14f44e06-4d56-4646-b9da-c6893f8d77b5

> FDA 483 for YB CHEMIA LLC on October 24, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: YB CHEMIA LLC
- Inspection Date: 2024-10-24
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: YB CHEMIA LLC in Baldwin Park, CA, was inspected from October 21-24, 2024, and received two observations. The inspection revealed deficiencies in the firm's quality control unit procedures, including issues with investigating out-of-specification results and change control management. Additionally, the purified water system was found to be inadequately designed and susceptible to contamination.

## Related Officers

- [Youkeun Kim](https://www.keypedia.com/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)

Company: https://www.keypedia.com/companies/yb-chemia-llc/e7ef6212-890b-4e94-81a6-2bd2cb0b57f9

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b