# FDA 483 - Immunomedics, Inc. - August 01, 2018

Source: https://www.globalkeysolutions.net/records/483/immunomedics-inc/786aac7a-cc2a-4972-bc85-3e5e3d6ff8d8

> FDA 483 for Immunomedics, Inc. on August 01, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Immunomedics, Inc.
- Inspection Date: 2018-08-01
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Immunomedics, Inc. in Morris Plains, NJ, was inspected regarding a clinical study and received a Form 483 with four observations. Deficiencies included failure to inform investigators of product issues, inadequate study monitoring, incorrect investigational drug labeling, and unvalidated electronic records lacking audit trails. These issues indicate significant concerns with clinical trial oversight and data integrity.

## Related Documents

- [483 - 2003-01-23](https://www.globalkeysolutions.net/records/483/immunomedics-inc/6366a984-045f-4a07-aa45-88b924fbb979)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/immunomedics-inc/38181c37-8c5a-4d62-b05f-61df7091f848)
- [483 - 2020-03-10](https://www.globalkeysolutions.net/records/483/immunomedics-inc/ed86ff8e-c9e9-48d9-a91b-aa7a531d5c87)
- [483 - 2018-08-14](https://www.globalkeysolutions.net/records/483/immunomedics-inc/6cd1946a-c9b5-4076-8fc0-9ca5c7959ca2)
- [483 - 2020-03-10](https://www.globalkeysolutions.net/records/483/immunomedics-inc/977f14da-5f9b-480a-9034-95991b8ebabc)

## Related Officers

- [Regulatory Officer](https://www.globalkeysolutions.net/people/peter-r-lenahan/c695dac2-5447-434b-801e-f95e6acf05f1)

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

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248