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Inspections will be much more streamlined once the FDA completes its sweeping reorganization, according to Deputy Commissioner Janet Woodcock. Read More
A litany of failures spanning inadequate personnel, manufacturing, cleaning and other lapses have resulted in the FDA serving a Form 483 to Advanced Cosmetic Research Laboratories (ACRL) following the agency’s July 2023 inspection of the Chatsworth, Calif., facility. Read More
In its continuing effort to step up post-pandemic enforcement activities, the FDA wrapped up 2023 by making public three Form 483s for as many Indian pharmaceutical manufacturers. Read More
Drug containers contaminated with wood, cellulose, brass and steel as well as multiple corrective and preventive actions (CAPA) to address mold are among the reasons the FDA listed in its untitled letter to Novartis Pharmaceuticals over its biological product Kymriah (tisagenlecleucel). Read More
In 2022, FDA inspections of both foreign and domestic drug manufacturing plants were still far below pre-COVID-19 pandemic levels, although the number of citations soared, a new study has found. Read More
Kilitch Healthcare India received an FDA Form 483 citing lack of sterility, incomplete laboratory records and inadequate laboratory controls, inadequate validation of aseptic processes and unclean and insanitary buildings following an eight-day October inspection of its Mumbai, Maharashtra sterile drug manufacturing facility. Read More
Dr. Reddy’s Laboratories Telangana, India, facility received yet another FDA Form 483 after an Oct. 19-27 inspection resulted in a 25-page report detailing powdery residue in multiple places on floors and equipment, pointing to a lack of cleaning and lack of equipment maintenance, among other lapses. Read More
The COVID-19 public health emergency may be officially over, but the temporary changes it provoked in regulatory assessments are here to stay, experts said during the 18th Annual FDA Inspections Summit last week. Read More