# FDA 483 - Immunomedics, Inc. - March 10, 2020

Source: https://www.keypedia.com/records/483/immunomedics-inc/ed86ff8e-c9e9-48d9-a91b-aa7a531d5c87

> FDA 483 for Immunomedics, Inc. on March 10, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immunomedics, Inc.
- Inspection Date: 2020-03-10
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Immunomedics, Inc. in Morris Plains, NJ, a drug substance intermediate manufacturer, was inspected by the FDA from March 2-10, 2020. The inspection revealed significant deficiencies across quality control, facility maintenance, equipment qualification, and data integrity, indicating a systemic lack of adherence to established procedures and controls. These issues pose a high risk to the microbiological control and overall quality of the drug substance intermediate.

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## Related Officers

- [Guislain Ulysse, Consumer Safety Officer](https://www.keypedia.com/people/guislain-ulysse-consumer-safety-officer/c10ca120-d418-44c2-a4fb-7c5082abe9ed)
- [Wayne E. Seifert, Consumer Safety Officer](https://www.keypedia.com/people/wayne-e-seifert-consumer-safety-officer/cac154a9-1840-4a78-a677-67ec0df0337f)
- [Andrea Siegel, Biologist](https://www.keypedia.com/people/andrea-siegel-biologist/d75dba01-0f8c-47a2-a10f-8713a8577cd0)
- [Willie Wilson, Lead Chemist](https://www.keypedia.com/people/willie-wilson-lead-chemist/ff565534-288c-426c-9c05-26d84f591023)

Company: https://www.keypedia.com/companies/immunomedics-inc/2741160b-58d0-47a4-abc6-1151bd4c6bfa

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