Massive eye drop recall reflects ongoing issues with manufacturing and FDA inspection

A California company has recalled more than 3.1 million bottles of lubricating eye drops because it had not properly tested – ...
Medical Device and Diagnostic Industry (MD+DI)

How to Safely Navigate the New QSMR & Succeed with FDA Inspections

Kim Trautman, an industry expert, shares some practical tips and tools for companies to navigate FDA’s new inspection process ...
Agri-Pulse

FDA continuing talks about shifting food inspection to states

The Food and Drug Administration is developing a plan to shift more food safety inspection responsibility to state agencies over the course of five years, according to two sources familiar with ...
Agri-Pulse

Shifting FDA food safety inspection to states has big challenges

After years of discussion, the Food and Drug Administration may shift responsibility for routine food safety inspection to the states. While industry and food safety experts say it's a logical move, ...

FDA cough drop recall: Check if your brand is on the list

Multiple popular cough drops were recalled nationwide due to possible quality concerns after an FDA inspection. Is your brand ...
Regulatory Affairs Professionals Society

FDA warns firm for inappropriate use of AI in drug manufacturing

The US Food and Drug Administration (FDA) has issued a warning letter to Purolea Cosmetics Lab for several violations of Good ...
Agence France-Presse

Routine FDA Inspection Completed Successfully With No Findings for Clinilabs

Clinilabs (“Clinilabs LLC”), a global, full-service contract research organization (CRO) specializing in CNS drug and device development, today announced it has successfully completed an inspection by ...
UPI

FDA to boost surprise inspections at foreign-based food, medical plants

May 6 (UPI) --The U.S. Food and Drug Administration said Tuesday it will expand its use of unannounced inspections at foreign manufacturing facilities. "For too long, foreign companies have enjoyed a ...