# FDA 483 - Immunomedics, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/immunomedics-inc/38181c37-8c5a-4d62-b05f-61df7091f848

> FDA 483 for Immunomedics, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immunomedics, Inc.
- Product Type: drugs
- Office Name: Division of International Drug Quality
- Summary: An FDA inspection of Immunomedics, Inc.'s Drug Substance Intermediate Manufacturing Facility in Morris Plains, NJ, revealed significant quality control and data integrity deficiencies. Observations included a failure to investigate a data integrity breach, inadequate retesting procedures, and a lack of control over raw materials and inventory. The facility also exhibited issues with environmental monitoring, design, and critical quality system processes like deviation handling, CAPA implementation, and cleaning validation, indicating a broad breakdown in GMP compliance.

## Related Documents

- [483 - 2003-01-23](https://www.keypedia.com/records/483/immunomedics-inc/6366a984-045f-4a07-aa45-88b924fbb979)
- [483 - 2020-03-10](https://www.keypedia.com/records/483/immunomedics-inc/ed86ff8e-c9e9-48d9-a91b-aa7a531d5c87)
- [483 - 2018-08-14](https://www.keypedia.com/records/483/immunomedics-inc/6cd1946a-c9b5-4076-8fc0-9ca5c7959ca2)
- [483 - 2020-03-10](https://www.keypedia.com/records/483/immunomedics-inc/977f14da-5f9b-480a-9034-95991b8ebabc)
- [483 - 2003-01-23](https://www.keypedia.com/records/483/immunomedics-inc/0d82ff12-8f49-4c77-900a-98b64af491f9)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)
- [Gunther H. Boekhoudt](https://www.keypedia.com/people/gunther-h-boekhoudt/b845bcf5-191b-4f26-bdd7-22b1b082cc1d)
- [Madushini N. Dharmasena](https://www.keypedia.com/people/madushini-n-dharmasena/c6dbff15-4c5f-475e-8ec1-581d8e65f76c)
- [investigator](https://www.keypedia.com/people/reyes-candau-chacon/f45d84c3-da5c-4958-bee8-084883ce8fef)

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

Office: https://www.keypedia.com/offices/division-of-international-drug-quality/f787ba47-67be-40ca-b4c5-4b664b9c1591