>>13650457simple.
I am director of product development for a medical device company. small company under 200million in sales, niche shit. but i used to run regulatory and know a thing or two about the process for development and production.
There is no way in hell they were able to get the production process through validation.
literally zero chance.
if i wanted to get a plant to start producing something well known and understood like freaking Advil gel tabs it would take 6 months minimum even assuming the FDA and inspectors did instant checks and responses.
yet somehow in less than a year they managed to build, install, test, validate, and train staff on production processes and tooling for a new injectable, using processes NEVER before mass produced, and got it into production?
Bullshit.
This is why Japan keeps finding that most of their lots are contaminated. Screw the development and the human testing, they didn't have enough time to get production right.
(fun fact a work friend of mine spent 5 months setting up for packing sterile gauze in a new built facility. FUCKING CLOTH! a well known, done everywhere, device with known tooling.)
