# FDA 483 - Celltrion Inc. - June 03, 2022

Source: https://www.keypedia.com/records/483/celltrion-inc/45210b1b-c256-4675-b160-8f544705ebe1

> FDA 483 for Celltrion Inc. on June 03, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Celltrion Inc.
- Inspection Date: 2022-06-03
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: CELLTRION, Inc. in Incheon, Republic of Korea, received a Form 483 with seven observations during an FDA inspection from May 23 to June 3, 2022, for deficiencies in drug substance and drug product manufacturing. The inspection revealed significant issues including inadequate procedures to prevent microbiological contamination, failure to establish proper process controls, and poorly designed and maintained equipment. Additionally, the firm was cited for insufficient investigation of deviations and inadequately validated manufacturing systems, indicating a lack of robust quality systems and controls.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)
- [Ralph M. Bernstein](https://www.keypedia.com/people/ralph-m-bernstein/72173dfb-24ae-42a1-af9e-1dc7da02ed87)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

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

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