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South Carolina drugmaker Trans Ox was rapped for major deviations in good manufacturing practices and quality controls after FDA investigators found cobwebs on equipment used to analyze drug batches. Read More
Pfizer’s Dalian, Liaoning, China, facility received a six-observation Form 483 from the FDA for retesting failed samples, poor record controls and using an open pit for a urinal. Read More
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