Compliance Corner: Abbott Quality VP Wants You To Talk About These 5 Things At Management Reviews
Monica Wilkins, divisional VP of medical, quality and strategic support for device-maker Abbott Laboratories, returns to Compliance Corner with more tips for management reviews. This time, she pinpoints five things that manufacturers should discuss during the meetings.
You may also be interested in...
9.1 Million Surgical Gowns Recalled By Cardinal Health; Firm Pins Sterility Woes On Contract Manufacturer
More than 9 million surgical gowns used in many everyday surgical procedures, including open heart surgery and knee replacements, have been recalled because of sterility concerns. Cardinal Health Inc. has placed the blame on a contract manufacturer that made the gowns in "unapproved locations that did not maintain proper environmental conditions."
Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 7)
A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this seventh installment of a 10-part series, the experts address the use of SMEs – subject matter experts – during inspections.
A maker of low-level LED light-therapy devices was cited by the US FDA for premarket, quality systems and Medical Device Reporting violations. It's just one of two device-related warning letters released by the agency this week.