Spectrum Laboratory Warned Again for GMP Failures
Just months after being rapped for violations at its Gardena, California facility, Spectrum Laboratory received another warning letter from the FDA, this time for similar GMP violations at its New Jersey API manufacturing plant.
Like the Gardena site, the New Brunswick facility lacked supply chain traceability for its APIs. “These failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate,” the agency said.
Specifically, the names and addresses of the original manufacturers of Spectrum’s repackaged APIs were left off certificates of analyses for products like potassium bicarbonate, sodium bicarbonate and progesterone (micronized powder).