FiercePharma

In addressing inspection shortfall, FDA says it's gaining more inspectors than it's losing

In its effort to play catch up after thousands of factory inspections were delayed during the coronavirus pandemic, the FDA is still lagging woefully behind and is unable to approach its pre-COVID ...
Fast Company

FDA drug-plant inspections still haven’t recovered from the pandemic, AP reports

As COVID-19 swept across the globe in early 2020, the Food and Drug Administration (FDA) pulled most of its safety inspectors from the field, creating a massive backlog of uninspected pharmaceutical ...
MD&M East

Wanted: More Participants for FDA’s Third-Party Inspection

In the past, FDA handled all inspections of manufacturing facilities. However, as U.S. manufacturers began to expand nationally and globally, the rising rate made it difficult for the limited number ...
JD Supra

FDA Drug Inspections Post–Workforce Reductions: Potential Implications and Practical Steps Forward

The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time ...
Yahoo Finance

FDA Regulations, Real-World Quality Management Systems and Data Integrity Compliance Tactics Training Webinar

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "Real-World Quality Management Systems and Data Integrity Compliance Tactics (July 30, 2025)" training has been added to ResearchAndMarkets.com's offering ...
MM&M

FDA inspectors again find dangerous breakdowns at an Indian factory supplying medications to U.S. consumers

ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox. U.S. inspectors have uncovered new and dangerous ...
JD Supra

FDA medical device inspections in 2025: What we're seeing, what we expected, and why you need the right expertise now

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...
FiercePharma

FDA inspectors ding one Dr. Reddy's plant in India, clear another

Recent FDA inspections of two separate Dr. Reddy’s manufacturing plants in India resulted in one facility getting the all clear, with another receiving a notice of Voluntary Action Indicated (VAI).
MM&M

FDA layoffs could compromise safety of medications made at foreign factories, inspectors say

This article originally appeared on ProPublica. ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox.
Food Safety News

FDA sends warning to sprouting operation after inspection initiated by Salmonella outbreak

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...
Fox News

Baby formula shortage: FDA response report cites outdated system, training issues

The Food and Drug Administration (FDA) acknowledged that its response to the infant formula shortage was hindered by outdated technology and delays. In a 10-page report, the agency said the tech that ...