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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
During its July 8-12 inspection, the agency noted that the firm received several complaints from customers about out-of-specification results they got after performing API tests on products they bought. Read More
A lack of product testing and a deficient quality unit resulted in a warning letter for New York-based Scientific Solutions Global, in addition to unapproved new drug violations. Read More
Dr. Reddy’s inspection woes continue following the FDA’s inspection of its Indian API manufacturing plant in Bollaram, Hyderabad, which revealed multiple violations and netted the pharma giant yet another Form 483. Read More
“Without testing each batch, you do not have scientific evidence that all drug product batches conformed to specifications before release,” the agency said. Read More