ProRx FDA Inspection Report

[Grogu]

ProRx (503b) recently had a lengthy FDA inspection in September and the results were just released (or became public). The inspection noted all types of issues and things are quite buzzing on the tirzepatidecompounded subreddit. The FDA was actually at the facility on the date that my most recent order was compounded when a lot of the observations were made. A few of the things in the report are benign (such as a labeling concern) but some things appear to be more problematic. I'm sitting on about 250mg of tirzepatide from these folks. I think most folks are continuing to use the medication.

I was already done with compounded tirzepatide, but this is icing on the cake for me. I'm not sure if others making the transition from compound to grey have any of this stuff in their stockpiles so I thought I should mention.

 

[Gr33dyOctopus]

ProRx (503b) recently had a lengthy FDA inspection in September and the results were just released (or became public). The inspection noted all types of issues and things are quite buzzing on the tirzepatidecompounded subreddit. The FDA was actually at the facility on the date that my most recent order was compounded when a lot of the observations were made. A few of the things in the report are benign (such as a labeling concern) but some things appear to be more problematic. I'm sitting on about 250mg of tirzepatide from these folks. I think most folks are continuing to use the medication.

I was already done with compounded tirzepatide, but this is icing on the cake for me. I'm not sure if others making the transition from compound to grey have any of this stuff in their stockpiles so I thought I should mention.

I do, and I've been following this. I have one 72mg vial of ProRx left. Well yuk, I paid $189 for that vial and going to use it, last. After the southend and bpi, maybe I won't use it, still have months before my girl and I finish our compound stash. Hard to say. But would I buy prorx again? Nope.

Unless compound goes to 100 a 70+mg vial ima ended up staying gray. I wouldn't have bought such a stash if id known how dirt cheap i could get it for, and how easy it is to reconsitute.

Fuck those money grabbing compounded, and fuck prorx for thier incredibly unsanitary and unclean workplace, WHILE they were being watched I might add.

 

[Grogu]

I do, and I've been following this. I have one 72mg vial of ProRx left. Well yuk, I paid $189 for that vial and going to use it, last. After the southend and bpi, maybe I won't use it, still have months before my girl and I finish our compound stash. Hard to say. But would I buy prorx again? Nope.

The general consensus over there is that most people are going to continue to use it. So, we'll probably hear about any problems real quick. I don't think that there will be any problems. And I will probably use it. Can't be worse than the Ouisa debacle and people took that and were okay.

I have 600mg of grey being delivered today and I'm so freaking excited, this ProRx issue ain't gonna rain on my day.

 

[Gr33dyOctopus]

The general consensus over there is that most people are going to continue to use it. So, we'll probably hear about any problems real quick. I don't think that there will be any problems. And I will probably use it. Can't be worse than the Ouisa debacle and people took that and were okay.

I have 600mg of grey being delivered today and I'm so freaking excited, this ProRx issue ain't gonna rain on my day.

Me neither, I really dont care either way, I mean if I can go gray sure ill end up using my prorx vial lol. And if they were 100 a pop? I'd use them lol

 

[Labcat]

It’s concerning how they deliberately were flouting the rules. Someone named it “toilet tirz” today. Fits, with bacillus coming out from that end of the body. (Someone on reddit tried to defend them by saying bacillus comes in an exotic japanese fermented food? 🤦‍♀️)
I’m trying to tell myself that their carelessness won’t have extra hidden problems that aren’t covered by preservatives or filtering - like other butt viruses.
Hepatitis, norovirus, gi/enteroviruses, other less common less nice viruses. (No one will really complain about gi symptoms since that will always be attributed to tirz, so we won’t really hear unless several die.) Of course grey materials without GMP could have that also, so maybe I’m just upset with them because this will encourage more companies to ignore the basic safety rules because enforcement is weak and really it’s kind of overwhelming so that most people will helplessly turn a blind eye. But it’s a loss for all of us if there’s no intermediate level of pharmaceuticals where we can pay more and get better quality.

 

[Calm Logic]

T60 from ProRx was my first vial. $550 for just the one vial, through my local independent pharmacy.

There has been previous inspection issues with ProRx, so not too surprising.

 

[Labcat]

T60 from ProRx was my first vial. $550 for just the one vial, through my local independent pharmacy.

There has been previous inspection issues with ProRx, so not too surprising.

Exactly. What was surprising to everyone was that this time the report called them out explicitly for ignoring the last one, they blew by the July deadline to have a plan for how they would attempt to fix the deficiencies. (They submitted garbage saying their way was fine). I think most of us find it really unnatural to think that anyone in our culture would go into a field like this and decide to just not do the accepted minimal standards.

 

[Calm Logic]

This reminds me why pharma in India has major trust issues since the FDA does inspections there but not as much, unless it is a big company like Sun Pharma.

 

[Labcat]

This reminds me why pharma in India has major trust issues since the FDA does inspections there but not as much, unless it is a big company like Sun Pharma.

We’ve been hearing more and more about inadequate standards of production on these generics. Our system rewards the worst quality :-(