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# 4 Observations in Immunomedics FDA-483
- URL: https://www.fdaweb.com/4-observations-in-immunomedics-fda-483/
- Published: 2019-03-13T12:00:00.000Z
- Updated: 2026-09-15T01:12:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143598

FDA has just released the [FDA-483](https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM633086?ref=fdaweb.com) issued following a 6/14-8/1/18 inspection at Immunomedics, a Morris Plains, NJ, clinical trial sponsor. The four observations were: 

- not all participating investigators were informed of new observations discovered by or reported to the sponsor;
- failing to ensure proper monitoring of the study and ensure the study is conducted in accordance with the protocol and/or investigational plan;
- the immediate package of the investigational new drug does not bear a label with the statement “Caution: New Drug—Limited by Federal (or United States) Law to Investigational Use”; and
- electronic records are used, but they do not meet systems validation and audit trail requirements to ensure that they are trustworthy, reliable, and generally equivalent to paper records.