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The FDA issued a warning letter to New Jersey drug compounder Ideal Specialty Apothecary citing “serious deficiencies” in its sterile drug production and for repackaging a cancer drug without a license. Read More
The FDA hit two U.S. and one Taiwanese drugmaker for a variety of shortcomings at their facilities, including quality oversight, inadequate testing and faulty equipment. Read More
Complete Pharmacy and Medical Solutions received a Form 483 from the FDA with seven observations stemming from a Jan. 9-23 inspection at its compounding facility in Miami Lakes, Florida. Read More
The FDA issued a warning letter to Enovachem for serious deviations from current good manufacturing practices for its APIs, in a follow-up to a Sept. 25-27, 2018 inspection of the firm’s Torrence, California manufacturing facility. Read More
The FDA hit OTC drugmaker SmartScience Laboratories with a Form 483 for multiple violations at its Tampa, Florida facility, including shoddy component storage and sanitizing. Read More
The FDA issued warning letters to three active pharmaceutical ingredient repackers, urging them to clearly identify the original manufacturer of the drugs — including opioids — to customers who use them in their finished products. Read More
Maple Rose Enterprises drew a lengthy Form 483 for a long list of transgressions at its Denver, Colorado facility, including shoddy conditions, equipment calibration letdowns and actions that risked contamination. Read More