Sandoz Subsidiary Called Out for Contamination Risk
January 14, 2019
The FDA cited Fougera Pharmaceuticals’ facility in Hicksville, New York, serving the Sandoz subsidiary a Form 483 for failing to follow procedures designed to prevent contamination of its drug products.
During a May 15-29 inspection, the investigator found that the firm failed to keep equipment involved in manufacturing processes clean during the tube filling process for one of its products, clindamycin phosphate gel.
Specifically, an operator removed plexiglass drum covers used to protect the product during manufacturing and placed the covers on top of a used drum outside the controlled HEPA airflow area.