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The FDA hit Optikem with a Form 483 after the agency’s investigator observed unsanitary conditions and problems with records in an inspection of the firm’s Denver facility. Read More
The FDA warned Tris Pharma for manufacturing adulterated products at its Monmouth Junction, New Jersey facility, citing failures to properly investigate product defects and other deficiencies found during a March inspection. Read More
The FDA cited API manufacturer CIL Isotope Separations after an inspection of its Xenia, Ohio facility revealed quality control issues, investigational deficiencies and other violations. Read More
The FDA hit Pfizer subsidiary Pharmacia & Upjohn with a Form 483 for inadequate employee training, poor equipment maintenance practices and inadequate sample inspection procedures. Read More
The FDA warned Tris Pharma for manufacturing adulterated products at its Monmouth Junction, New Jersey facility, citing failures to properly investigate product defects and other deficiencies found during a March inspection. Read More
As part of its heightened focus on data integrity the FDA has increased the sophistication of its inspections to identify hard-to-find data violations, according to a former CDER official who shared data integrity compliance tips in an FDAnews webinar. Read More