USFDA 483 to Novo Nordisk Cite Lapses in Production Records, Water Quality Testing

FDA has published the USFDA Form 483 issued to Novo Nordisk API manufacturing facility at Kalundborg, Denmark. The site (FEI 3002807751) which manufacture the block buster Semaglutide was inspected by USFDA investigators Lindsey Brown, Ralph M. Bernstein, Maxwell Korang-Yeboah, and Zachary Kraus in March 2024.

The key deficiencies reported in the USFDA 483 include Insufficient water quality testing for microbial control, Incomplete manufacturing instructions lacking critical details in production records, and inadequate process validation documentation. Master Production records, process validation documentation and submissions to the agency failed to include and evaluate several unit operations, critical process parameters and inprocess controls. The USFDA Form 483 also raised concern that the SOP for “Behaviour in API production facilities” did not include product contact material to minimise contamination risks.

The USFDA Form 483 observes that sample volume used to test the water quality is insufficient, failing to represent the capacity of the water system. Additionally, there was inadequate information demonstrating that the water used for purification of drug substance was adequately controlled for total microbial counts and objectionable organisms

Interestingly the 483 also raises the issue of changes to production schedules without quality oversight.

USFDA 483 Novo Nordisk Kalundborg facility (FEI 3002807751)

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