FDA 483 - Novo Nordisk A/S - March 25, 2024

An FDA Form 483 was issued to Novo Nordisk NS (FEI: 3002807751), a drug substance manufacturing facility, detailing eight observations related to quality system and manufacturing deficiencies.

**Key Observations:**

1. **Water System Testing:** The routine sample volume for water quality and purity testing is insufficient to represent the water system's capacity. 2. **Water System Microbial Control:** Inadequate information to demonstrate control of total microbial counts and objectionable organisms in water used for drug substance purification. 3. **Undisclosed Manufacturing Operations:** Substance manufacturing and processing unit operations, such as recovery equipment and process steps, are not included in the submission to the Agency. Critical process parameters, in-process controls, and routine drug substance results are also inadequately described. 4. **Incomplete Master Production Records:** Master production and control records lack complete manufacturing and control instructions, specifically critical details regarding certain unit operations. 5. **Inadequate Process Validation Documentation:** Validation of the drug substance manufacturing process, including data for critical process parameters and in-process controls, is not appropriately documented. 6. **Inadequate Written Procedures:** SOP Q0800455 "Behaviour in API production facilities and Sourcing warehousing facilities" ver. 1.0 is inadequate as it does not describe behavior for product contact material to minimize contamination risk to the drug substance. 7. **Lack