ND ALTERNATIVES?

Okay, I literally just drove down to our facility on a Sunday after seeing this post. If my team screwed up, I am going to make damn sure I know about it as quickly as possible. We have so many processes and procedures in place now that a mistake like this is next to impossible, but I always get that little fear in the back of my mind when stuff like this pops up. So if was going to rest easy today, the only way forward was for me to immediately check things out myself. I pulled a 50 gram sulbutiamine jar, 30 gram Cognizin jar, and for shits and giggles a 30 gram oxiracetam jar from the shelf and headed into the lab.

To start off, we have an insane amount of processes and procedures in place to prevent things like this from happening. We also have a very detailed QC/QC team to catch things if they do happen, preventing them from affecting customers, and extra verifications to ensure things are being done properly on an ongoing basis. Our powder filling line uses an $8,000 load cell that was custom made for us by a company in Germany, due to how accurate it needed to be over a large range. We even had the head engineer from that company fly out to Arizona to install and calibrate the load cell. It's a very accurate piece of equipment. We also use extremely accurate scales to check the weights of a percentage of units coming off the production line as an extra verification during the QA/QC process. These scales are regularly calibrated and verified to be working properly. In addition to this, we check and verify the starting and ending weights of everything that goes into a lot, and calculate the loss to ensure the math is correct for the unit size that was made. Then even on top of that, two units of every lot are chosen at random by our lab. One is kept sealed as a retained reference from that lot, and the other is taken back into the lab; where our analytical team not only makes sure it is in spec, but runs a sample through our FTIR/ATR again to ensure nothing was mixed up doing production. Only then does a lot get approved to go to the shelf. Every step along the way is tracked, monitored, and signed off on by multiple people on my team, both electronically and physically. Those records, and the sealed retained sample units, are kept for 2 years past the date of the last sale of that lot. We have and insane amount of tracking and verification to ensure things are in spec at all times.

For the testing I did today, I used our Ohaus AX224 scale. That has a capacity of 220 grams, with a readability down to 0.1mg. That scale auto calibrates every time you turn it on, and is manually verified using calibration weights on a monthly basis as well. It's about as accurate as you can get. I zeroed out the scale between each measurement, and double checked my numbers for accuracy.

The 50 gram sulbutiamine jar I opened contained 50,196.5mg of sulbutiamine, or 196.5 milligrams over the 50 gram amount. That's just what I could get out of the jar. There was more on the walls of the jar, and I spilled a little bit. So the total weight of the contents was actually higher than that. That number is without the desiccant. The desiccant itself weighed 1,207.6mg. The total weight of the sealed jar before I opened it was 77,447.5mg. Everything was perfectly in spec.

Here is the weight of the contents on the sulbutiamine jar. 50,196.5 milligrams

Here is the weight of the sealed sulbutiamine jar. 77,447.5 milligrams

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Now onto the Coginzin. The 30 gram jar of Cognizin that I opened contained 30,088.5mg, or 88 milligrams over the 30 amount. Again, it will be a bit higher than that, as you can't get absolutely everything out of the jar. Again, this is without the desiccant. The desiccant in that jar weighed 1,227.2mg. The total weight of the sealed jar of Cognizin was 57,610.6mg. Everything was perfectly in spec on this one as well.

Here is the weight of the contents on the Cognizin jar. 30,088.5 milligrams

Here is the weight of the sealed Cognizin jar. 57,610.6 milligrams

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Now onto the random oxiracetam jar. The 30 gram jar of oxiracetam that I opened contained 30,051.6mg, or 50 milligrams over the 30 gram amount. Again, all considerations from the previous two jars apply to this one as well: there is more than that in the jar, and the weight is without the desiccant. The desiccant in this jar weighed 1,110.7mg. The total weight of the sealed oxiracetam jar was 50,031.6mg. Everything was perfectly in spec on this one as well. Remember, injection molded plastic jars and caps vary in weight. The jar and cap on this one weighed 7 grams less than the one Cognizin was in. This is why you can't just measured filled jars and compare them on a like-for-like basis.

Here is the weight of the contents on the oxiracetam jar. 30,051.6 milligrams

Here is the weight of the sealed oxiracetam jar. 50,031.6 milligrams

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So everything I weighed was completely in spec. That's not to say it is impossible that you may have gotten one out of spec. However, the likelihood that you got multiple jars out of spec on the same order, and that they were multi-grams out of spec, it very very unlikely. So I have a few questions for you. What scale did you use? When did you last calibrate the scale, or have you ever calibrated it? How did you calibrate the scale? What method did you use to weigh the contents of the jars? Did you weigh them with the desiccant or without? What is your order number? What are the lot numbers of each jar? Obviously my impromptu investigation is not a formal one. If you give us the detailed information regarding your specific case, my team can run a formal OOS investigation this week.

Hopefully it doesn't need to be said here, but we do not scam people, under fill, or take shortcuts for any reason. We are very detailed, accurate, and diligent with out quality control and assurance. We take things like this very seriously, and I personally care about the trust people have put in me and my company over the years. I would never break that trust for something as silly as under-filling jars of powder. If mistakes are made, I will get to the bottom of it, and put steps in place to ensure they don't happen again. It's how I have always operated, and why people trust me. I don't think we made a mistake here, though. I think it is likely a measurement error. However, we will certainly do a more formal OOS investigation if we get the appropriate data to do it.