IMMUNOMEDICS INCFDA Warns Immunomedics for Data Integrity Breach, Other Violations
The FDA sent a warning letter to 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.
"Interviews by Immunomedics personnel involved in the event were conducted under attorney/client privilege and no additional documentation is available, therefore no assessment could be made during the prelicense inspection," the agency said.
The firm also had issues with differential pressure in GMP areas of different classifications. Specifically, it didn--t properly maintain air pressure; the pressure between a Class C room and Class D corridor was out of action levels in 37 measurements between July 24 and August 1, 2018, the agency said. Additionally, not all adjacent rooms with different air classification had alarms for low pressure differentials.
The agency called out the facility's design, noting that there were no drains present in certain rooms that required them. There was also no standard operating procedure for liquid containment and disposal after catastrophic spills.
No signed quality agreement existed between the company and its supplier of cell culture media and buffers, solutions and chromatography resins used in certain manufacturing processes. The FDA redacted the name of the supplier.
Read the full warning letter here: www.fdanews.com/12-07-18-immunomedicsinc483.pdf. -- James Miessler
Release date: 20181210
fdanews.com
Source: Drug Industry Daily
Publish Date: 12/10/2018 |
