# FDA 483 - AGC Biologics A/S - November 05, 2019

Source: https://www.keypedia.com/records/483/agc-biologics-as/f86fe017-848d-474e-b2f5-bf381d2e68cd

> FDA 483 for AGC Biologics A/S on November 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AGC Biologics A/S
- Inspection Date: 2019-11-05
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of AGC Biologics A/S in Soeborg, Denmark, revealed significant deficiencies across manufacturing, quality assurance, and laboratory operations. The firm failed to follow master batch records, adequately investigate recurring deviations, implement corrective actions, and maintain scientifically sound laboratory controls. These issues indicate a lack of robust quality systems and control over drug substance manufacturing processes.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/agc-biologics-as/95a4aa35-7bbc-4c3e-94c9-a98e3e30da8e)

## Related Officers

- [Reyes Candau-Chacon, Ph.D, Microbiologist](https://www.keypedia.com/people/reyes-candau-chacon-phd-microbiologist/7e93758f-43c6-49cb-bd5d-c240f910802d)
- [Chih-Jung Hsu, Ph.D., Staff Fellow](https://www.keypedia.com/people/chih-jung-hsu-phd-staff-fellow/986d155a-d64e-494b-a338-7bf4e244e4b7)
- [Riley Myers, Ph.D.; Lead Biologist](https://www.keypedia.com/people/riley-myers-phd-lead-biologist/f9f7b2db-0820-4e31-95bf-27aa2b6568ea)

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