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The FDA hit Chinese manufacturer CAO Medical Equipment with a warning letter citing drug and API testing violations at its Langfang, Hebei facility. Read More
The FDA handed BASF a Form 483 after finding that the drugmaker’s Quincy, Florida, facility put its API products at risk of contamination and failed to follow procedures for OOS results. Read More
The FDA also cited the compounder for labeling violations for products lacking the required labeling statements “This is a compounded drug” or “Not for resale.” Read More
“In addition, your firm failed to have written procedures for re-evaluating the cleaning validation program upon entrance of new active ingredients in the manufacturing facility,” the agency said in the Form 483, adding that the firm did not consistently perform risk assessments on drug substances manufactured on shared equipment — such as reviewing each new drug substance’s toxicological data, solubility and pharmacological effects. Read More
Gottlieb said the agency is “going to be putting many more firms on notice that we’re aware that they’re manufacturing cell and tissue products that are subject to our oversight.” Read More
The firm concluded that only one of its manufacturing processes for valsartan involved NDMA, but the FDA discovered multiple batches made through a different process that were also contaminated with NDMA. Read More
The FDA came down on API manufacturer Hanmi Fine Chemicals for cleaning validation and data control violations observed at its Gyeonggi-do, Korea plant. Read More
The FDA hit Hybrid Pharma with a warning letter, citing the Deerfield Beach, Florida, pharmacy for producing drugs that failed to qualify for exemptions from FDA oversight for compounded drugs. Read More
Indian drug manufacturer SkyLark CMC drew a warning letter from the FDA by denying the agency investigator access to its manufacturing facility in Ahmedabad, Gujarat. Read More
The firm gave no assurance that samples and batch records from commercial batches it manufactured before the data integrity breach were not impacted. Read More
The FDA has agreed to recognize drug and active pharmaceutical ingredient GMP inspections carried out by authorities in Belgium, Denmark, Finland, Latvia and Estonia, updating the 1998 mutual recognition agreement between the U.S. and the European Union. Read More