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 warned Inova Genomics Lab for marketing pharmacogenomic and whole gene sequencing tests without the agency’s approval or clearance. Read More
Specification developer Circulatory Technology failed to submit medical device reports within 30 days of receiving complaints that its Better Bladder device failed during use, collapsing as a result of leaks, an Aug. 22 to Sept. 26, 2018... Read More
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