# FDA 483 - Celltrion Pharm, Inc. - September 14, 2023

Source: https://www.globalkeysolutions.net/records/483/celltrion-pharm-inc/63dbea5b-92ee-4735-a241-d0e54a9509ac

> FDA 483 for Celltrion Pharm, Inc. on September 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Celltrion Pharm, Inc.
- Inspection Date: 2023-09-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Celltrion Pharm, Inc. in Cheongju-si, Korea, a drug manufacturer, revealed significant deficiencies in their quality management system. The firm failed to adequately establish procedures for finished device acceptance, corrective and preventive actions, and management review. These issues indicate a lack of robust controls over product quality and system oversight.

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## Related Officers

- [Thai T. Duong](https://www.globalkeysolutions.net/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.globalkeysolutions.net/companies/celltrion-pharm-inc/481a4273-bf7e-4b37-8cd8-08b977ba576b

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