FDA Foreign Inspection Gap Grows as U.S. Drug Imports Surge, New Study Finds

Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study ...
Yahoo Finance

QSIT Is Ending: How to Achieve Audit Readiness for Medical Devices Under FDA QMSR, Upcoming Webinar Hosted by Xtalks

In this free webinar, see how audit readiness can be strengthened as the FDA transitions from QSIT to QMSR. Attendees will learn about the implications of the shift from inspection-based QSIT to a ...
JD Supra

The QMSR Goes Live and FDA Implements a New Medical Device Inspection Technique

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice regulations with the international ISO 13485 standard, Medical ...
Today

More than 75,000 cases of eye care products recalled, FDA enforcement report says

More than 75,000 cases of eye drops have been voluntarily recalled by a pharmaceutical testing lab after an audit by the Food & Drug Administration identified "deviations" from Current Good ...
WNDU

FDA took months to react to complaint about Abbott infant formula factory, audit finds

STURGIS, Mich. (AP) - The U.S. Food and Drug Administration took more than 15 months to act on a whistleblower complaint it received about conditions at an Abbott Nutrition factory that was at the ...
MLive

FDA took months to react to complaint about Michigan infant formula factory, audit finds

The U.S. Food and Drug Administration took more than 15 months to act on a whistleblower complaint it received about conditions at an Abbott Nutrition factory that was at the center of a nationwide ...