Novo Nordisk Pharmaceutical Industries LP – FDA EIR, Jul 13, 2023

An FDA Pre-approval inspection of Novo Nordisk Pharmaceutical Industries LP in Clayton, NC, was conducted from July 6 to July 13, 2023. The inspection, guided by Compliance Program 7346.832 and ICH Q7 Good Manufacturing Guidance for Active Pharmaceutical Ingredients, aimed to assess the firm's readiness for manufacturing Semaglutide active pharmaceutical ingredient (API) for New Drug Application #213051 Supplement 6.

Inspectors issued an FDA Form 483 with two main observations. Firstly, the firm failed to thoroughly investigate unexplained discrepancies, evidenced by recurrent identification of objectionable organisms like Serratia marcescens and Enterobacter species in intermediate Semaglutide API batches between February and June 2023. Previous investigations and corrective actions proved ineffective in identifying the root cause. Secondly, microbial controls were found deficient. This included the lack of established microbial limits for in-process API materials where contamination was observed. Furthermore, water used in production was not required to be evaluated for objectionable organisms unless total microbial counts exceeded 100 CFU/mL, potentially allowing for uninvestigated contamination at lower levels.

Novo Nordisk management, represented by Corporate Vice President API Mr. Leonardo Costa Siqueira, committed to providing a written response to the FDA Form 483 within 15 business days. The FDA emphasized the firm's responsibility to correct these conditions to avoid potential regulatory actions.