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Following a month-long inspection in August, the FDA reprimanded Catalent for numerous quality lapses observed at its Bloomington, Ind., plant — where the drugmaker has performed manufacturing activities for both Moderna’s and Johnson & Johnson’s COVID-19 vaccines. Read More
Particulars of the 13 inspection observations that stopped the FDA from approving biosimilars developer Alvotech’s biologic license application (BLA) for AVTOC2 draw a picture of a manufacturing facility seriously out of compliance with good manufacturing practice. Read More
The FDA issued a 10-observation Form 483 to Omega & Delta’s manufacturing facility in Carolina, Puerto Rico, following an April 25 to May 6 inspection that unearthed an inadequate water system, an absent quality control unit and other quality lapses, including the presence of rodent excrement. Read More
Puerto Rico-based drug manufacturer Skyless was slapped with a five-observation 483 from the FDA that centered on the plant’s lack of any manufacturing procedures and training for employees. Read More
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