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The FDA hit Indian injectable drugmaker Auronext Pharma over violations found during a February inspection of the company’s Bhiwadi, Rajasthan facility. Read More
In another twist in the worldwide recall of the contaminated blood pressure medication, valsartan, the FDA released two Form 483 reports issued to the API’s manufacturer in China after inspections in 2016 and 2017. Read More
The FDA hit German drug and API manufacturer Boehringer Ingelheim with a Form 483 for recordkeeping shortcomings at its Ingelheim am Rhein facility. Read More
Compounding pharmacy Kelley-Ross & Associates in Seattle drew a warning letter from the FDA after an agency inspection in July found numerous sanitation violations. Read More
The FDA called out Indian API manufacturer Vamsi Labs for failing to complete investigations at its Solapur, Maharashtra facility, including one for API batches shipped to the U.S. Read More
The firm “did not collect microbiological water samples prior to cleaning the system when the previously scheduled sanitation cycle was not run,” the agency said. Read More