Are FDA Inspections of Overseas Production Facilities a Thing or Not?

With the outbreak of potentially deadly transmittable infections from the bacterium P. aeruginosa apparently sparked by contaminated eye drops manufactured in India, we once again confront how dependent we are on health items (including ones that can kill or blind you) produced overseas in largely unregulated manufacturing facilities. And what did the FDA find when they found their way there? They found a facility grossly in violation of cleanliness standards.

We are talking about a treatment-resistant bacteria that can be spread person to person, rendering those in congregate living situations (think, nursing homes) particularly vulnerable to transmission. You can learn about the FDA’s foreign drug inspection program here. Mind you, this report predates the COVID pandemic, but the author is still crowing that roughly half of all previously never inspected facilities have now been inspected.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s