The Indian manufacturing facility that made generic eye drops sold under CVS, Target, Rite Aid, and Walmart brands had a slew of manufacturing violations, including allowing workers to regularly perform their roles barefoot and failing to document bacterial contamination, according to an inspection report released by the Food and Drug Administration.
At the time of the FDA’s initial warning, the agency said it had found bacterial contamination in critical production areas of the Mumbai facility.
FDA inspectors found the facility was in poor condition generally, noting cracked floors, peeling paint, water stains, and dust build-up.
Most surprisingly, the inspectors observed barefoot employees working in a sterile area of the facility, where they should have been wearing shoes—plus gowns, gloves, and shoe booties.
Inspectors also noticed that if workers at the facility detected bacterial contamination that registered over an “action” or “alert” level, the testing results were not recorded.
At the start of the year, an outbreak of extremely drug-resistant bacterial infections linked to EzriCare Artificial Tears came to light.
The original article contains 454 words, the summary contains 166 words. Saved 63%. I’m a bot and I’m open source!
This has been going on ever since pharmaceuticals were outsourced to India and China. This was done to reduce FDA oversight. The FDA is still allowed to enter these facilities as a condition of allowing imports but the cost of sending inspectors to the other side of the planet means that there is much less scrutiny.
If you want to want to be terrified of all medicine try reading this blog “warning letter of the week” where they find the most insane FDA warning letter issued every week to some pharmaceutical company:
No idea about China, but the Indian government relaxed a lot of safety rules during Covid so pharmaceutical companies could produce medicines as fast as possible. This has resulted in many companies making substandard or even harmful products.
Yikes. Suddenly that cry of “The generic stuff is just as good!”
Are going to be drowned out by the “the generic stuff is made in barefoot factories in india with constant failed safety inspections!” And then we are all forced to buy marked up products.
This is the best summary I could come up with:
The Indian manufacturing facility that made generic eye drops sold under CVS, Target, Rite Aid, and Walmart brands had a slew of manufacturing violations, including allowing workers to regularly perform their roles barefoot and failing to document bacterial contamination, according to an inspection report released by the Food and Drug Administration.
At the time of the FDA’s initial warning, the agency said it had found bacterial contamination in critical production areas of the Mumbai facility.
FDA inspectors found the facility was in poor condition generally, noting cracked floors, peeling paint, water stains, and dust build-up.
Most surprisingly, the inspectors observed barefoot employees working in a sterile area of the facility, where they should have been wearing shoes—plus gowns, gloves, and shoe booties.
Inspectors also noticed that if workers at the facility detected bacterial contamination that registered over an “action” or “alert” level, the testing results were not recorded.
At the start of the year, an outbreak of extremely drug-resistant bacterial infections linked to EzriCare Artificial Tears came to light.
The original article contains 454 words, the summary contains 166 words. Saved 63%. I’m a bot and I’m open source!
This has been going on ever since pharmaceuticals were outsourced to India and China. This was done to reduce FDA oversight. The FDA is still allowed to enter these facilities as a condition of allowing imports but the cost of sending inspectors to the other side of the planet means that there is much less scrutiny.
If you want to want to be terrified of all medicine try reading this blog “warning letter of the week” where they find the most insane FDA warning letter issued every week to some pharmaceutical company:
https://chemjobber.blogspot.com/search/label/warning letter of the week
Seems like capitalism working for the benefit of people as a whole.
/s
so does that mean that the EU is unaffected, or have we just been relying on the FDA to check factories?
No idea about China, but the Indian government relaxed a lot of safety rules during Covid so pharmaceutical companies could produce medicines as fast as possible. This has resulted in many companies making substandard or even harmful products.
Yikes. Suddenly that cry of “The generic stuff is just as good!”
Are going to be drowned out by the “the generic stuff is made in barefoot factories in india with constant failed safety inspections!” And then we are all forced to buy marked up products.
Brand name stuff comes from the same factories. Pharmaceutical manufacturing has been completely outsourced mostly to avoid regulatory oversight.
My eye drops are made in Switzerland. ¯\_(ツ)_/¯