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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
“Unless you test each batch, you do not know whether it conforms to finished product specifications and is suitable for release,” the agency said. Read More
Baxter subsidiary Claris Injectables was hit with a warning letter for significant water damage, falsely recording data and neglecting to properly investigate out-of-specification results at its Ahmedabad, Gujarat facility. Read More