FDA 483 - Immunomedics, Inc. - August 14, 2018

During an FDA inspection conducted from August 6 to August 14, 2018, Immunomedics, Inc., a drug substance intermediate manufacturing facility in Morris Plains, NJ, received a Form FDA 483 listing significant observations. These observations highlight deficiencies in the company's adherence to current Good Manufacturing Practices (cGMP).

Key issues included a critical data integrity breach involving the manipulation of bioburden samples, misrepresentation of test procedures, and backdating of batch records, which the quality control unit failed to adequately investigate. The FDA noted a lack of assurance that previous batch records were unaffected. Other concerns involved inadequate retesting procedures, particularly for microbiology samples, and an insufficient raw material sampling and testing program, including failure to test critical product-contact materials for bioburden.

Further violations encompassed deficient inventory management, lacking audit trails and reconciliation for raw materials, and an inadequately mapped warehouse. Environmental controls were compromised by poorly maintained differential pressure in GMP areas and a facility design lacking drains in critical rooms. The company also lacked a signed Quality Agreement with a key supplier and failed to trend bioburden results in chromatography resins.

Finally, the inspection identified weaknesses in the quality system, specifically inadequate deviation investigations, unfulfilled corrective and preventive actions (CAPAs), and significant delays in initiating and closing deviations. Cleaning procedures for critical equipment were unvalidated, and procedures to prevent product contamination during dispensing operations were found to be inadequate. Immunomedics is required to address these serious observations to ensure product quality and compliance.