# FDA 483 - Goodwin Biotechnology, Inc. - May 16, 2025

Source: https://www.keypedia.com/records/483/goodwin-biotechnology-inc/70d41cf2-798a-40f1-b25e-15fbf40f6188

> FDA 483 for Goodwin Biotechnology, Inc. on May 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Goodwin Biotechnology, Inc.
- Inspection Date: 2025-05-16
- Product Type: drugs
- Office Name: Florida District Office
- Summary: Goodwin Biotechnology Inc. in Plantation, FL, was cited for significant deficiencies across its drug substance intermediate manufacturing operations. The inspection revealed widespread issues including inadequate contamination controls, unsanitary facility conditions, compromised data integrity in computerized systems and production records, and a lack of proper laboratory and quality unit oversight. These findings indicate a systemic failure to adhere to cGMP requirements.

## Related Documents

- [483 - 2019-04-10](https://www.keypedia.com/records/483/goodwin-biotechnology-inc/ada67b91-cb64-457a-b980-959f36e4368e)

## Related Officers

- [Zhong Li](https://www.keypedia.com/people/zhong-li/18545b20-7fa5-4850-9dd4-cffb40c41f8d)
- [Doan M. Singh, PharmD, MS, Lead, Regulatory Specialist](https://www.keypedia.com/people/doan-m-singh-pharmd-ms-lead-regulatory-specialist/563fb5c9-8146-47dc-b456-4ce62e1f3d7e)
- [Zhong Li, Ph.D., Senior Regulatory Specialist](https://www.keypedia.com/people/zhong-li-phd-senior-regulatory-specialist/8239f257-d22a-47ff-af8a-248ff122d717)
- [Priscilla Amador Do Amaral](https://www.keypedia.com/people/priscilla-amador-do-amaral/aaa92850-10d1-4b87-a13e-7c4cf3cd00da)
- [Danielle M.E. Jones, Ph.D., Microbiological Scientist](https://www.keypedia.com/people/danielle-me-jones-phd-microbiological-scientist/dc19bcbb-54b3-4a39-b9e1-374b473aacbd)

Company: https://www.keypedia.com/companies/goodwin-biotechnology-inc/ecf6d534-aaa3-4d43-b900-12cc1172cc90

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9