Novo Nordisk says it will have no impact on products currently marketed in the US
The US Food and Drug Administration (FDA) has sent Novo Nordisk a warning letter following an inspection last March that found cGMP violations at the company’s facility in Bagsvaerd, Denmark.
The FDA said in the letter to Chief Executive Lars Rebien Sorensen that Novo Nordisk had not established or followed the appropriate written procedures designed to prevent microbiological contamination of sterile drug products at the plant.
This is the second European manufacturer to receive a warning letter from the US regulator in as many months. In January, German injectable drugs manufacturer Hameln Pharmaceuticals was warned for not following appropriate procedures and for not training staff properly.
The FDA cited a number of violations at the Novo Nordisk plant, including a failure to collect enough environmental monitoring samples, which the regulator said: ‘suggests a pattern that raises concerns regarding your environmental programme’.
Operators working in the aseptic core during the manufacture of batches were observed wearing goggles that had not been adequately sterilised and had two openings on the top.
The quality unit failed to investigate and quantify the impurity peak during HPLC analysis
The company’s quality unit also failed to investigate and quantify the impurity peak during its high-performance liquid chromatography (HPLC) analysis. The FDA asked Novo Nordisk to describe how the HPLC is cleaned to avoid residues from adhering to the system.
The inspectors also noted that Novo Nordisk’s environmental monitoring for non-viable particulates was performed a substantial distance away from the filling station on the aseptic fill line. The FDA asked the company to provide a diagram describing the positioning of each non-viable particle-monitoring probe on the line and a justification for each position.
Novo Nordisk must also provide an update on its current manufacturing and US supply plans for the injectable product produced at the plant.
Novo Nordisk said it submitted its response to the warning letter on 28 December 2012, and does not expect the letter to have an impact on products currently marketed in the US.