Inspections and Audits

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. Read More

FDA Warns Three Drugmakers for GMP Slipups

Three U.S. drug manufacturers were hit with warning letters over shortcomings encountered at their facilities, including data integrity concerns, improper equipment calibration and unproven water systems. Read More