FDA's Letter to Tailor Made Compounding Pharmacy

I was warning people about Tailor Made, since they were doing zero testing of their products. I found an inspection report from 2018 that said they don't even test for ID of incoming peptides they sell.

https://www.fda.gov/media/123771/download

OBSERVATION 9

Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.

a.) Specifically, your firm does not perform any identity testing on incoming raw materials.

b.) Your firm receives raw materials and peptides from suppliers both domestically and internationally. However, your firm has never audited any of these suppliers.

Then you can pull more relevant quotes from the one you linked.

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.

So they did not even have fucking SOPs for microbiological analysis, much less were following them...

Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

So they did not even have a system to properly clean the rooms things were made in, much less the products themselves.

Your firm failed to conduct at least one test to verify the identity or each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals.

ZERO analytical testing! They did not even fucking test for ID on things coming in, and just used China manufacturer COAs. Might as well just write an identity and purity number on a napkin with crayon. That's about as good as a Chines supplier COA.

Your firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of automatic, mechanical, electronic equipment, or other types of equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product.

That's not surprising, since they didn't even sterilize the rooms. Doing initial quality and operational quality analyses are a HUGE part of being cGMP compliant. We fly people out from the manufacturers of our equipment, like UPLC, FTIR, UV-VIS, etc. every year for OQ analyses. Those technicians run standardized analytical tests to ensure our equipment is still operating within spec. It's a big part of knowing your numbers are right. If you buy a $20,000 UV-VIS, you also have to spend $5,000 per year for the maintenance and OQ. Otherwise you don't know the numbers are accurate. Tailor Made wasn't even testing anything, so they had no lab equipment to run OQ on. However, you need to do IQ/OQ on EVERYTHING. This includes encapsulation machines, scales, water purification systems, air filters... everything.

Your firm failed to thoroughly investigate any unexplained discrepancy of failure of a batch or any of its components to meet any of its specifications, whether or no the batch has already been distributed.

OOS investigations, or out of spec investigations, are a massive part of running a supplement company, much less a compounding pharmacy. You have to have systems in place to investigate breakdowns in your processes, unexpected results, customer complaints, or any analytical results that fall outside of your expected parameters. Then you need to have corrective actions or explanations for the specifics in those investigations. It's a very laborious and detailed process, but most places don't do it. Our OOS packets can be 20-30 pages long, depending on the type of investigation it was. All the little shit people don't think about that needs to happen in the background takes up significant time and resources, but is necessary for people to be able to trust that what you are saying is true. If you don't have proper processes and procedures in place to empirically measure the things you are doing, you can't even trust your own data, much less get customers to trust you?

Companies like this are what give the FDA justification to shut down parts of the industry, and take more control. Fuck companies like this! This is why honest companies have to tiptoe around regulatory agencies. The FDA thinks everyone is like this, and they would be right most of the time. However, it doesn't have to be this way! We can show that the industry can self-regulate. There are plenty of margins in the peptide and SARM space. There is no reason to not spend the money on proper quality control equipment and procedures, other than you just don't give a shit about people's safety. It's all about money. Doing the things I spoke about correctly costs a lot of money. That's money the owners could be using to buy themselves Lambos. "Nobody else in the peptide space is doing it, so why should we?" This is why the industry is where it is. Nothing will change until consumers hold companies accountable, and companies in the industry treat things seriously.