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The FDA has informed Icelandic biosimilars developer Alvotech that it must address issues found in the March 2022 preapproval inspection of the company’s Reykjavik manufacturing facility before the agency will consider final approval of the Biologics License Application (BLA) for AVTOC2, a biosimilar to AbbVie’s Humira (adalimumab). Read More
During an inspection of BPI Labs in Evanston, Wyo., the FDA’s investigator found multiple issues with production and quality control records, as well as areas of potential product contamination. Read More
Inadequate procedures to minimize the risk of contamination earned Lupin Limited a Form 483 following a March 22 to April 4 FDA inspection of its facility in Palghar, Maharashtra, India. Read More
Westwood Laboratories’ Azusa, Calif., contract manufacturing facility lacks adequate sterility procedures, according to a Form 483 issued following a March 24 to April 5 inspection. Read More
Indian generic drugmaker Sun Pharmaceuticals drew an FDA Form 483 for allegedly falsifying internal documents covering batch records, among other deficiencies, following an agency inspection of the company’s plant in Mohali, Punjab, from Aug. 3 to 12. Read More
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