# FDA 483 - Celltrion Pharm, Inc. - July 22, 2024

Source: https://www.globalkeysolutions.net/records/483/celltrion-pharm-inc/dfa000f0-147d-4a6c-a079-9dbbab126e71

> FDA 483 for Celltrion Pharm, Inc. on July 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Celltrion Pharm, Inc.
- Inspection Date: 2024-07-22
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Celltrion Pharm, Inc., a sterile drug manufacturer in Ochang-eup, South Korea, revealed significant deficiencies across three observations. The firm failed to establish and follow procedures to prevent microbiological contamination, lacked adequate employee training for drug product manufacturing, and had unwritten quality control unit responsibilities and procedures. These issues indicate a moderate to severe level of non-compliance with cGMP regulations.

## Related Documents

- [483 - 2023-09-14](https://www.globalkeysolutions.net/records/483/celltrion-pharm-inc/63dbea5b-92ee-4735-a241-d0e54a9509ac)

## Related Officers

- [Investigator?](https://www.globalkeysolutions.net/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

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

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8