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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
A drug manufacturer in Málaga, Spain was cited for failing to test active pharmaceutical ingredients from China and other serious GMP violations. Read More
The FDA hit Puerto Rico drugmaker Caribe Holdings with a Form 483 for not cleaning equipment and utensils at suitable intervals to prevent product contamination and for long delays in validating cleaning procedures. Read More
The FDA hit OTC drugmaker Results RNA with a second warning letter in just over a year, this time for GMP violations at its Orem, Utah facility. Read More
Over-the-counter drug manufacturer Church and Dwight was hit with a Form 483 for violations at its Lakewood, New Jersey facility, including incomplete laboratory records and shortcomings in its microbiological testing. Read More
Detroit-based drug manufacturer Vertellus received a Form 483 with 7 observations from an FDA inspection of its Zeeland, Mich. facility. The Mar. 25-April 9 inspection revealed problems across the facility’s quality, materials, and laboratory systems. Read More