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The FDA hit Minnesota generic drug manufacturer Upsher Smith Laboratories with a Form 483 over cleaning and batch production violations at its Plymouth facility. Read More
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