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The FDA issued a Form 483 to active pharmaceutical ingredient manufacturer IDT Australia citing quality shortcomings and other deviations observed during a December inspection of its Boronia, Victoria, facility. Read More
The FDA sent a warning letter to compounder Gipsco Investment cautioning that it’s not exempt from the agency’s oversight and was producing adulterated and misbranded products. The action stems from a June 2017 inspection of the Cleveland, Ohio, facility. Read More
Edge Biologicals was hit with a Form 483 for violations at its Memphis, Tennessee facility, including inadequate environmental monitoring, poor complaint handling and incomplete recordkeeping observed during a March inspection. Read More
The FDA cited Milbar Laboratories, an OTC drug manufacturer based in East Haven, Connecticut, for repeat inspection observations including failure to sterilize a purified water system. Read More
Edge Biologicals was hit with a Form 483 for violations at its Memphis, Tennessee facility, including inadequate environmental monitoring, poor complaint handling and incomplete recordkeeping observed during a March inspection. Read More
The FDA cited Milbar Laboratories, an OTC drug manufacturer based in East Haven, Connecticut, for repeat inspection observations including failure to sterilize a purified water system. Read More
Certification documents for the firm’s ISO 5 aseptic processing areas did not describe the testing conditions, such as with operations ongoing, equipment in place and personnel present. Read More
Minneapolis, Minnesota-based Fairview Compounding Pharmacy was hit with a Form 483 after an FDA inspection in April revealed serious sterilization deficiencies. Read More