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The FDA handed Illinois Tool Works’ drug manufacturing facility in Olathe, Kan., a six-observation Form 483 citing several repeated quality lapses following an inspection from March 28 to April 1. Read More
The FDA slapped Akorn, a sterile drug manufacturer, with a Form 483 over unexplained discrepancies and batch failures following an inspection of its Decatur, Ill., plant conducted from March 28 to April 8. Read More
Boise, Idaho-based Episciences was issued an 8-observation Form 483 for missing testing procedures, deficient cleaning and other quality lapses. Read More
Precision Nuclear of Virginia landed a Form 483 following a March 22 to 25 inspection of its positron emission tomography (PET) drug facility in Roanoke, Va., where FDA officials observed multiple quality lapses. Read More
The FDA issued I3 Pharmaceuticals a Form 483 for multiple quality deficiencies observed during an inspection of its Warminster, Pa., facility from Feb. 7 to Feb. 22. Read More
An annual report from the FDA’s Center for Drug Evaluation and Research (CDER) says the agency’s drug manufacturing inspection activities fell short of CDER’s self-determined goals in fiscal year 2021, primarily due to COVID-related restrictions. Read More
The FDA hit Eywa Pharma’s Cranbury, N.J., drug manufacturing facility with a three-observation Form 483, citing inadequate investigations of deviations and other quality lapses. Read More
The FDA issued skincare drug product developer Clinical Formula a five-observation Form 483 for lacking an effective quality control unit and other serious deficiencies observed during a November-December 2021 inspection of its Newport Beach, Calif., facility. Read More
The FDA hit Carlsbad, Calif.-based SAFC Carlsbad — a MilliporeSigma property — with a seven-observation Form 483 following a December 2021 inspection, citing inadequate handling of biohazardous materials and other quality lapses. Read More
The FDA issued a warning letter to a contract testing laboratory at Miami University in Oxford, Ohio, for significant deviations from current good manufacturing practice (cGMP), including falsified data. Read More
The FDA has issued a Form 483 to a drug manufacturer and repackager in Saint Paul, Minn., for multiple deficiencies observed during a Nov. 1-18, 2021 inspection of its facility, including several that were observed during previous inspections. Read More