Arrow International sterilization software validation deficient, FDA tells company.
This article was originally published in The Gray Sheet
ARROW INTERNATIONAL STERILIZATION SOFTWARE VALIDATION DEFICIENCIES are detailed by FDA in a warning letter to the firm released the week of Aug. 25. The FDA correspondence specifically cites the catheter manufacturer's Asheboro, North Carolina facility for failure "to appropriately validate the software" for "computer controlled sterilizers" as required by FDA's good manufacturing practices regulations.
You may also be interested in...
Pain relief product sales grew 27% and upper respiratory sales 35% for the week ended 7 March as consumers respond to COVID-19, according to Nielsen data noted in a Jefferies report on consumer health purchasing trends. Private label market share is up slightly, while OTC purchases continue primarily in conventional stores.
Managing partner Corey Goodman said venBio didn’t have trouble closing its fund, because the venture capital firm prepared its investors for an economic downturn months ago.
The US FDA has proposed moving two categories of hepatitis C diagnostics to class II from class III because they pose relatively low risk.