Novo Nordisk Pharmaceutical Industries LP – FDA EIR, May 13, 2022

An FDA pre-approval inspection of Novo Nordisk Pharmaceutical Industries LP's Clayton, NC facility, conducted from May 9-13, 2022, focused on evaluating the site's adherence to current Good Manufacturing Practices (cGMP) for the non-sterile active pharmaceutical ingredient (API) Semaglutide, destined for NDA #213051 Oral Semaglutide / Rybelsus® tablets. This was the facility's inaugural FDA inspection. The inspection resulted in three significant observations documented on an FDA Form 483.

Key issues identified included the company's failure to recognize *Burkholderia cepacia* as an objectionable organism within its water system, deficiencies in equipment cleaning procedures to prevent cross-contamination, and the absence of established written procedures to prevent contamination of equipment, raw materials, and active pharmaceutical ingredients. These findings indicated non-compliance with the Food Drug and Cosmetic Act's adulteration provisions and cGMP requirements, as guided by CPGM 7346.832 Pre-Approval Inspections and ICH Q7 Guidance.

Novo Nordisk management, represented by Corporate Vice President API Mr. Leonardo Costa Siqueira, acknowledged the observations and committed to submitting a written response within fifteen business days. The FDA cautioned that these conditions could lead to legal sanctions, including the potential withholding of the New Drug Application approval.