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A Puerto Rican drugmaker has landed a 13-observation Form 483 over numerous GMP procedural issues and a lack of oversight at its plant in Salinas. Read More
Sponsors with pending NDAs and ANDAs backed by trials conducted at India’s Semler Research Limited must return to the drawing board because of data integrity issues, the FDA said. Read More
Sponsors with pending ANDAs backed by trials conducted at India’s Semler Research Limited must return to the drawing board because of data integrity issues, the FDA said. Read More
Two more compounding pharmacies are in the FDA’s crosshairs, with one faulted for failing to maintain proper sterility while the other was accused of compounding without valid prescriptions. Read More