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A Houston, Texas, API and finished drugmaker received an 11-observation Form 483 for a litany of cGMP violations, including failing to investigate complaints about caterpillars and poppy seeds in vials of finished product. Read More
Lapses in quality management systems and adverse event reporting topped the list of major deviations found during EU postmarking inspections last year: 18 sites were cited for QMS issues and 13 for problems with AE reporting. Read More
A federal judge in New Jersey ordered a Hamilton, N.J., company charged with marketing unapproved and misbranded suppositories to destroy its stock and discontinue manufacturing the products. Read More
A new study looking at large-scale clinical trials funded by NIH shows the number reporting positive results dropped precipitously in the years since they were required to preregister on the clinicaltrials.gov website. Read More
Sipra Labs landed an FDA warning letter for major cGMP violations, including failure to investigate batch discrepancies and failure to establish and document testing methods. Read More
Genzyme received a 16-observation Form 483 from the FDA for not conducting risk assessments and other quality lapses at a facility where bulk drug substances are made. Read More