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A Pennsville, New Jersey API manufacturer earned itself a Form 483 for quality violations at its facility, including failure to reject faulty drug substances and inadequate investigations of discrepancies. Read More
The FDA hit Bensenville, Illinois-based Empire Distributors with a warning letter for selling an unapproved new drug product containing the active ingredients for FDA-approved erectile dysfunction drugs. Read More
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