US FDA's Inspection Decisions To Be Swayed By Facility "History" With Foreign Regulators
Leveraging foreign surveillance inspections could help FDA ensure more sites are inspected more often.
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Though they remain unpaid, hundreds of furloughed FDA employees will return to duty to conduct routine surveillance inspections of high-risk manufacturing facilities.
FDA Aims For Transparency In Releasing New Risk-Based Site Selection Model For Determining Who Is Inspected Next
US FDA explains new risk-based model for selecting manufacturing sites for inspection in US and abroad. By releasing information about the model, FDA aims to shed some transparency in its decision-making process.
As Zhejiang Huahai works to rid its valsartan API manufacturing process of NDMA impurity, two competitors also have launched recalls after discovering the probable carcinogen in their valsartan API. Meanwhile, US FDA confronts Huahai over handling of impurities that visited chromatograms in the form of ghost peaks.