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Skates1616

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I’m very familiar with this space, specifically parenteral manufacturing.

The real challenge lies in the expectations the FDA has set for manufacturing. Over time, the regulatory space has been heavily influenced by academic-driven theoretical scenarios for microbiological contamination. While well-intentioned, these theoretical risks often drive overly stringent requirements that don’t always reflect real-world manufacturing risks.

As a result, it’s becoming prohibitively expensive to manufacture drugs for the U.S., especially sterile injectables.

And truly it gets worse every year…

Running the same in 6 family member homes, I have not had one “tech support” call needed since installation last year. I moved them all from the original OnHubs which were also set it and forget it…