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An operator removed plexiglass drum covers used to protect the product during manufacturing and placed the covers outside the controlled HEPA airflow area. Read More
The firm also failed to secure all of its analytical equipment. For example, one instrument used to run identification tests on raw materials generated raw data that could be deleted. Read More
The FDA issued a warning letter to Akorn’s sterile drug manufacturing facility in Decatur, Illinois on Jan. 4 over poor aseptic conditions observed during an inspection last spring. Read More
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. Read More
The FDA cited Johnson Memorial Cancer Center’s Enfield, Connecticut sterile drug manufacturing facility after investigators found sterility problems, airflow issues and mold contamination during an Oct. 1 to Oct. 19, 2018 inspection. Read More