FDA 483 - Immunomedics, Inc. - August 06, 2018

The FDA Form 483 details multiple deficiencies at Immunomedics Inc., a pharmaceutical manufacturer. The quality control unit lacks authority to investigate critical deviations, exemplified by a February 2018 data integrity breach involving manipulation of bioburden samples, misrepresentation of integrity test procedures, and backdating of batch records. This breach's scope, including its impact on pre-February 2018 process validation and commercial batches, remains unassessed due to attorney/client privileged interviews.

The retesting procedure for out-of-specification (OOS) results is inadequate, allowing routine retesting for initial OOS results and delayed non-conformance report initiation for microbiology samples. The raw material sampling and testing program is insufficient; specifically, a critical solution from a vendor has never been sampled, and product-contact materials used in cell culture are not tested for bioburden, leading to contamination deviations.

Inventory audit trails and raw material reconciliation procedures are lacking, with no records tracing raw material use, undocumented discarded materials, and an unsearchable Excel spreadsheet for inventory. The warehouse lacks adequate mapping, and quarantined and released items are stored side-by-side.

Environmental controls are deficient, with inadequate maintenance and monitoring of differential pressure in GMP areas, and unalarmed pressure differentials between critical rooms. The facility design is inadequate, lacking drains in rooms and a spill containment/disposal SOP. Production bioreactor materials are held in bags.

No signed Quality Agreement exists with