# FDA 483 - AGC Biologics A/S - Unknown Date

Source: https://www.keypedia.com/records/483/agc-biologics-as/95a4aa35-7bbc-4c3e-94c9-a98e3e30da8e

> FDA 483 for AGC Biologics A/S on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AGC Biologics A/S
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of AGC Biologics, Inc. in Copenhagen, Denmark, a drug substance manufacturer, revealed two significant observations. The firm failed to ensure adequate personnel training for sample handling operations, leading to high sample failure rates and impacted product quality. Additionally, the inspection noted a lack of timely implementation of change control for test method document updates, resulting in reoccurring deviations.

## Related Documents

- [483 - 2019-11-05](https://www.keypedia.com/records/483/agc-biologics-as/f86fe017-848d-474e-b2f5-bf381d2e68cd)

## Related Officers

- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)
- [Zhenzhen Liu](https://www.keypedia.com/people/zhenzhen-liu/e166c0fc-7555-49ff-ad84-e9be50c542ce)

Company: https://www.keypedia.com/companies/agc-biologics-as/49ad0b3f-1a32-433e-b4e1-b6643981671c

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