FDA Audit Shows Data Manipulation at Immunonedics Plant

FDA Audit Shows Data Manipulation at Immunonedics Plant

April 12th, 2019 // 6:29 pm @

Immunomedics received a complete response letter from FDA last month that related to cGMP issues in manufacturing regarding its breast cancer antibody drug conjugate. When they were pressed by pharma analysts, executives for the pharma company dodged questions about if it was related to a preapproval inspection last year.

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Now, FDA has issued the FDA 483 from the audit that shows major problems with data integrity at the plant in Morris Plains NJ, where sacituzumab goviecan is being produced. The 13 observation 483 stated during the audit that investigators found major data integrity problems. Some of these included bioburden samples that were manipulated, misrepresentations of a test procedure in the batch records, and backdating of several batch records.

FDA stated it was uncertain if data integrity problems affects batches from earlier dates as Immunomedics was questioning plant personnel per attorney client privilege and no more documentation was made available.

The 483 also noted the raw material sampling was poor, and records were unavailable to track history. There also were problems with cleaning and the possibility of contamination.

During a briefing with analysts last month, the CEO of Immunomedics, Michael Pehl said the findings from the 483 were  unexpected, and he believed that all of the cGMP issues could be addressed for the cancer treatment, but he did not provide any more details until company officials were able to meet with FDA.

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