# 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

- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)
- [Andrea Siegel](https://www.keypedia.com/people/andrea-siegel/7436ec58-8c64-4ad9-a6cf-7c2039c51447)
- [Willie Wilson](https://www.keypedia.com/people/willie-wilson/d7028341-a417-41c9-ac00-997bfda722bb)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

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