# FDA 483 - Goodwin Biotechnology, Inc. - April 10, 2019

Source: https://www.globalkeysolutions.net/records/483/goodwin-biotechnology-inc/ada67b91-cb64-457a-b980-959f36e4368e

> FDA 483 for Goodwin Biotechnology, Inc. on April 10, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Goodwin Biotechnology, Inc.
- Inspection Date: 2019-04-10
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Goodwin Biotechnology, Inc., a drug contract manufacturing and laboratory in Plantation, FL, was inspected by the FDA. The inspection revealed significant deficiencies in laboratory controls, including issues with method validation, bioburden testing, and sterility testing. Additionally, the firm failed to thoroughly review unexplained discrepancies and exhibited inadequate quality control unit procedures, impacting various aspects from SOP revisions to visual inspection and data integrity.

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## Related Officers

- [Microbiologist](https://www.globalkeysolutions.net/people/susan-t-hadman/512c3274-4da8-4f5a-a081-965ab5ec84e6)
- [Jose F. Velez](https://www.globalkeysolutions.net/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)

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

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6