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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
Contract drug manufacturer Jubilant HollisterStier drew a Form 483 after the FDA observed contamination risks at the firm’s Kirkland, Quebec facility. Read More
The FDA hit Vital Laboratories with a Form 483 for incomplete batch production records, inadequate complaint handling and unapproved labeling, among other violations, at its Vapi, Gujarat facility. Read More
The FDA hit Korean drug supplier Barox with a warning letter for quality control, drug labeling and product storage issues at its Seongnam, Gyeonggi facility. Read More
Indian drug manufacturer SkyLark CMC drew a warning letter from the FDA by denying the agency investigator access to its manufacturing facility in Ahmedabad, Gujarat. Read More