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The FDA zapped three more compounders over sterility issues, with two Tennessee firms receiving Form 483s and a California facility getting hit with a warning letter. Read More
The second phase of ISPE’s quality metrics pilot program — which kicked off this month — will continue as planned, despite differences in its metrics and the quality data the FDA plans to collect, says the co-chair of ISPE’s quality metrics team. Read More
Drugmakers in the EU have less than eight months to conduct risk assessments of all the excipients they use, under good manufacturing practices guidelines imposed by the European Commission. Read More
Particulates have forced Teva to voluntarily recall lots of its anticancer therapy Adrucil for the second time since May, after silicone rubber pieces from a filler diaphragm and fluorouracil crystals were found in six lots of the product, totaling over 30,000 vials. Read More
Indian active pharmaceutical ingredient maker Mahendra Chemicals was hit with an FDA warning letter for cGMP deviations including data integrity issues — the latest in a crackdown on foreign API makers. Read More
The FDA has identified 10 quality data points that finished dosage form and active pharmaceutical ingredient makers will need to collect to calculate four quality metrics for each product they produce. Read More
If the FDA were to implement a quality metrics program similar to the collection of the 16 metrics used in ISPE’s Quality Metric Pilot Program, the cost would be about $75,000 annually per company, or $35 million across the industry, ISPE says. Read More
The FDA’s crackdown on compounding pharmacies that lack sterile processing controls continued with warning letters to facilities in Florida and Arkansas — bringing to 18 the number of compounders cited this year. Read More