> ## 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 Released
- URL: https://www.fdaweb.com/immunomedics-fda-483-released/
- Published: 2020-04-02T12:00:00.000Z
- Updated: 2026-09-14T16:09:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146484

FDA has released the [FDA-483](https://www.fda.gov/media/136631/download?ref=fdaweb.com) with 10 observations from a 3/2-3/10 inspection at Immunomedics, Inc., a Morris Plains, NJ, drug substance intermediate manufacturer. The observations were: 

- failing to establish procedures and controls designed to prevent microbiological contamination of the drug substance intermediate and related components;
- failing to have in writing and fully follow responsibilities and procedures applicable to the quality control unit;
- standard operating procedures are inadequate or not followed;
- failing to exercise appropriate controls over computers or related laboratory and production systems;
- the redacted process for bioreactors is a semi-automated process with enhanced control and monitoring of the process performed by protocol;
- failing to adequately maintain and inspect facilities and equipment;
- procedural controls are inadequate to assure the validated state is maintained;
- analytical method verification studies were not performed for specified procedures during the lot release and stability testing of a redacted item at Immunomedics;
- failing to complete qualification of equipment and to establish procedural controls for use; and
- the redacted automated cell thawing equipment in the redacted area are not properly qualified to comply with their intended purpose.