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# FDA Releases Immunomedics EIR
- URL: https://www.fdaweb.com/fda-releases-immunomedics-eir/
- Published: 2019-05-08T12:00:00.000Z
- Updated: 2026-09-15T01:25:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144060

FDA has just released the Establishment Inspection Report (EIR) from an 8/6-8/14/18 inspection at Immunomedics, Morris Plains, NJ. The EIR says a 13-item FDA-483 was issued to the company at the close of the inspection with these observations: 

- the quality control unit lacks authority to investigate critical deviations of approved procedures;
- there is no assurance that samples and batch records from a redacted intermediate process validation and commercial batches manufactured prior to 2/2018 were not impacted by the data integrity breach;
- retesting procedure for the redacted intermediate is inadequate;
- the raw material sampling and testing program is inadequate;
- the firm lacks procedures for inventory audit trail and for tracking and reconciliation of raw materials used to manufacture the redacted intermediate;
- differential pressure between GMP areas of different area classification is not adequately maintained and monitored;
- design of the facility is inadequate in that no drains are present in the purification rooms and there is no SOP for liquid containment and disposal after a catastrophic spill;
- there is no signed quality agreement between a redacted organization and Immunomedics;
- no procedure is in place for redacted intermediate trending of results;
- deviation investigations and CAPA implementation are inadequate;
- deviation initiation and closing times are inadequate;
- cleaning of downstream equipment is not validated or verified; and
- the procedure to prevent contamination of the redacted intermediate is inadequate for a product stored under specified conditions.