# FDA 483 - Amicogen (China) Biopharm Co., Ltd. - March 31, 2025

Source: https://www.globalkeysolutions.net/records/483/amicogen-china-biopharm-co-ltd/af80b3ff-0e36-4ea6-b51e-20d5de269d65

> FDA 483 for Amicogen (China) Biopharm Co., Ltd. on March 31, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amicogen (China) Biopharm Co., Ltd.
- Inspection Date: 2025-03-31
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Amicogen (China) Biopharm Co., Ltd. in Jining, China, received a Form 483 with three observations during an FDA inspection. The firm's sterile drug product manufacturing operations were found to be inadequately controlled, posing a risk of microbiological contamination due to issues with equipment, manual processes, and environmental controls. Additionally, the inspection revealed deficiencies in airflow visualization studies and incomplete batch production and control records.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)

Company: https://www.globalkeysolutions.net/companies/amicogen-china-biopharm-co-ltd/f3e49436-c792-47f7-ba7a-17d61c7306af

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