# FDA 483 - Celltrion Inc. - February 27, 2024

Source: https://www.keypedia.com/records/483/celltrion-inc/f5ab1f32-2192-4aed-afb0-e72bdcc2519c

> FDA 483 for Celltrion Inc. on February 27, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Celltrion Inc.
- Inspection Date: 2024-02-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: This 483 report for Celltrion Inc. details significant deficiencies in aseptic processing, quality unit oversight, and laboratory controls. Issues include inadequate media fill validation, poor environmental monitoring, destruction of original control documents, and insufficient investigations into out-of-specification results. The findings indicate a lack of assurance in the sterility, quality, and purity of drug products manufactured for the US market.

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## Related Officers

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- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
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- [Hyung-yul Lee](https://www.keypedia.com/people/hyung-yul-lee/a790a804-2e43-4901-8d7d-0c656c464f0f)

Company: https://www.keypedia.com/companies/celltrion-inc/d3991ec8-423b-4554-9d67-72bc27a8658b

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