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Unrestricted access to electronic records and a series of quality control deficiencies resulted in a seven-observation 483 for a specialty drugmaker based in Maryland. Read More
The FDA served Auro Pharmacies — a California-based compounder — with a warning letter after the agency determined the firm produced products under insanitary conditions. Read More
The FDA hit CTX Lifesciences with a warning letter for several failures at its India-based drug manufacturing facility and the quality of its active pharmaceutical ingredients. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use issued positive opinions for eight medicines — including two biosimilars. Read More
An FDA inspection of Isometric Pharmacy’s Salt Lake City facility revealed several GMP violations that rendered its drugs adulterated and resulted in a warning letter. Read More