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The FDA cited USV Private for multiple violations at its drug manufacturing facility in Daman, western India, including invalidating out-of-specification (OOS) results without any justification. Read More
Canadian sterile drug manufacturer Viatrexx was hit with an FDA warning letter for serious violations of aseptic practices observed during an agency inspection. Read More
Cosmaceutical Research Lab was hit with an FDA warning letter for serious violations uncovered during an inspection of the firm’s manufacturing facility in British Columbia, Canada. Read More
The average inspection score for pharma manufacturing sites in fiscal 2019 dropped slightly from the year before, but scores for over-the-counter and homeopathic products significantly dragged down the global average, says a new FDA report. Read More
The FDA cited active pharmaceutical ingredient (API) manufacturer Abbey Color for failing to properly qualify its suppliers and other quality lapses at its Philadelphia, PA facility. Read More
Federal lawmakers yesterday criticized the effectiveness of the FDA’s foreign inspections program, expressing outrage that the controversial anti-malaria drug hydroxychloroquine, which has been used to combat COVID-19, came from foreign plants that have never been inspected. Read More
European officials cited Indian API maker Dishman Carbogen Amcis for serous quality failures found during an inspection of its facility in Gujarat. Read More
An FDA investigator found lapses in good manufacturing practices in an inspection of Time-Cap Laboratories’ drug manufacturing and repackaging facility in Farmingdale, New York. Read More