# Celltrion Pharm Inc – FDA 483, Aug 10, 2026

Source: https://www.keypedia.com/records/483/celltrion-pharm-inc/cfed34fd-e60f-4f50-aca4-a3c5bd268d80

> FDA 483 for Celltrion Pharm Inc on August 10, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Celltrion Pharm Inc
- Inspection Date: 2026-08-10
- Product Type: drugs
- Office Name: Foreign - CVM (Bioresearch Monitoring)
- Summary: An FDA inspection of Celltrion Pharm Inc. in Cheongju-si, Republic of Korea, a sterile drug manufacturer, revealed significant deficiencies in aseptic processing, cleaning procedures, and quality control. Observations included falsified cleaning records, inadequate validation of visual inspection equipment and personnel, and insufficient environmental monitoring, indicating a serious lack of control over sterile manufacturing operations.

## Related Officers

- [Drug National Expert](https://www.keypedia.com/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)
- [company_representative](https://www.keypedia.com/people/nelson-n-ayangho/917cb8ea-904d-41a1-b522-2351d3cb1f74)
- [Mabany Lizardi](https://www.keypedia.com/people/mabany-lizardi/adcca71c-e996-44e5-9827-d1aa2773e832)

Company: https://www.keypedia.com/companies/celltrion-pharm-inc/55f6e589-c93e-472c-8632-71f7c9418352

Office: https://www.keypedia.com/offices/foreign-cvm-bioresearch-monitoring/53e70745-81df-4996-bd75-60b60e3be0c4