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The FDA flagged sterile drug manufacturer Pharmacy Resources for a host of quality violations observed in a Jan. 9-29 inspection of its Denver, Colorado facility, including inadequate cleaning and wearing nonsterile apparel. Read More
The FDA cited Lupin’s Novel Laboratories facility in Somerset, New Jersey, for its handling of out-of-specification results and other violations observed in a Dec. 3-21, 2018 inspection. Read More
Drug compounder ImprimisRx landed itself in hot water with the FDA for producing adulterated, misbranded and unapproved drug products at its Irvine, California facility, activity that prompted the FDA to issue the firm a warning letter. Read More
Luen Fook Medicine’s Singapore facility drew a warning letter from the FDA for making unapproved drug claims and for repeat quality violations. Read More
The FDA warned generic drugmaker RIJ Pharmaceuticals for multiple violations at its Middletown, New York facility, including inadequate water quality. Read More
Issues ranging from unqualified personnel to inadequate recordkeeping netted Honolulu, Hawaii-based positron emission tomography (PET) drugmaker Hamamatsu/Queens PET Imaging Center a Form 483 from the FDA. Read More
The FDA hit Infusion Partners of Canfield, Ohio with a warning letter over shoddy manufacturing practices for sterile drugs including antibiotics. Read More
The FDA has cracked down once more on Indian pharma giant Aurobindo Pharma for manufacturing deficiencies at one of its facilities, slamming the company with yet another Form 483 over drugmaking violations and quality unit concerns. Read More
Adulterated products and contamination risks landed Columbia, Missouri compounder Apollo Care a warning letter from the FDA, in a follow up to a Form 483 report the agency issued after a March 2018 inspection. Read More
Sterile drugmaker Unither Manufacturing drew a Form 483 for quality deficiencies at its Rochester, New York facility, including investigations of out-of-specification results. Read More