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The FDA issued a warning to a Belleville, N.J. OTC drugmaker US Pharmaceuticals for serious failures in its purified water system including high microbial counts. Read More
The FDA hit Illinois-based generic drugmaker Akorn with an extensive warning letter for violations at its Somerset, New Jersey facility — the company’s second warning of the year. Read More
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