The FDA cited Immunomedics for a host of violations — including its handling of a data integrity breach — observed at its Morris Plains, New Jersey, drug substance manufacturing facility between August 6 and 14.
The investigation revealed that the firm’s quality control unit didn’t have the authority to investigate critical deviations that occurred at the facility — namely a February 2018 data integrity breach, which didn’t trigger a deviation. This breach included manipulated bioburden samples, misrepresentation of an integrity test procedure in the batch record, and backdating of batch records, such as dates of analytical results.
In addition, the firm gave no assurance that samples and batch records from commercial batches it manufactured before the data integrity breach were not impacted by it, and the agency was unable to conduct a proper assessment.
