> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Immunomedics FDA-483 Has 13 Observations
- URL: https://www.fdaweb.com/immunomedics-fda-483-has-13-observations/
- Published: 2019-02-13T12:00:00.000Z
- Updated: 2026-09-15T01:03:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143367

FDA has released the FDA-483 with 13 observations issued following an 8/6-8/14/18 inspection at Immunomedics, a Morris Plains, NJ, drug substance intermediate manufacturing facility. Specific observations were: 

- the quality unit lacks authority to investigate critical deviations of approved procedures, specifically involving a 2/2018 data integrity breach that did not trigger a deviation;
- there is no assurance that samples and batch records from the process validation and commercial batches manufactured before 2/2018 were not affected by the data integrity breach;
- retesting procedure for a redacted item is inadequate;
- the raw material sampling and testing program is inadequate;
- the firm lacks procedures for inventory audit trail and reconciliation of raw materials used to manufacture a redacted item;
- 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 specified rooms and there is no standard operating procedure for liquid containment and disposal after a catastrophic spill;
- there is no signed quality agreement between Immunomedics and a redacted firm that supplies cell culture media and all buffers, solutions, and chromatography resins used for redacted items;
- no procedure is in place for redacted trending of results;
- deviation investigations and corrective and preventive action implementations are inadequate;
- deviation initiation and closing times are inadequate;
- cleaning of redacted equipment is not validated or verified; and
- the procedure to prevent contamination of a redacted item under specified circumstances is inadequate for specified conditions.