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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
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
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
Paris-based AB Science, a developer of tyrosine kinase inhibitors, received an FDA warning letter for failing to report adverse events promptly and lapses in clinical trial monitoring. Read More
A Montana compounder was hit with a 17-observation Form 483 due to issues with its sterile processing, contamination controls and other GMPs. Read More
Nosch Labs, a maker of active pharmaceutical ingredients, was hit with a five-observation FDA Form 483 after workers at its Veliminedu Village, Chityal Madal, India, facility were observed passing off APIs that failed to meet quality control standards. Read More