Biologics

FDA Tags Data Integrity, Inventory Lapses in AGC Biologics 483

FDA has cited AGC Biologics for deficiencies in laboratory data controls and inventory management at its Bothell, WA, drug substance manufacturing site, according to a just-released Form FDA-483.

FDA investigators inspected the facility 4/2025 and cited inadequate review of laboratory data associated with in-process and final bulk drug substance release testing. Among the issues, investigators said raw analytical data did not match information contained in the final analytical packet used to document release results for a specific lot. The discrepancy, tied to testing for residual impurities as part of final bulk drug substance release, was not identified during a quality control review completed in 11/2024.

The agency also reported that a quality control analyst demonstrated the ability to delete original electronic data files generated by certain analytical instruments used in final bulk testing. According to the Form 483, there was no routine, system-level audit or review in place to ensure the integrity and completeness of electronic data submitted for quality review.

In addition, the agency cited deficiencies in the qualification of instruments used for in-process monitoring of bioreactors. Investigators noted that an instrument qualified in 2016 lacked defined acceptance criteria for accuracy in its final report, despite being used to monitor cell viability during bioreactor production of drug substance. The qualification report, which included protocol deviations, was not reviewed and approved until 4/2024, years after the instrument entered service.

In a separate observation, investigators flagged inaccuracies in the documentation of critical material inventory, specifically involving working cell bank (WCB) vials stored in liquid nitrogen. The agency observed that the company’s electronic inventory system indicated a certain number of WCB vials for a specified lot stored in a liquid nitrogen vessel. Paper records for the same lot reflected a different quantity, and a physical count of the storage location identified yet another number of vials.

The working cell bank in question is used as starting material for upstream cell culture processes to produce drug substance under an approved BLA, according to the report.

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