Question 1: Does your company have a dedicated quality department? If so, how can the consumer access this?
We have our own fully staffed and equipped QA department but they are not open to the public. They implement our testing standards and maintain our FDA mandated records as well as directly interact with the FDA on inspections and other regulatory mandates. Our QA department interfaces with the FDA with authority outside of the our management chain of command. Much like the purpose of Inspectors General in the US government, our QA department is a watchdog on our senior most management (all the way up to the CEO, COO and VP of Manufacturing) to make sure we are never improperly motivated, etc.
Question 2: What testing methodology do you use for your raw materials?
We own and operate our own FDA inspected manufacturing facility (we have been inspected and passed multiple times). We follow all regulations and GMP guidelines and take pride in our attention to quality. We do in-house testing on all ingredient lots and send out OTC active ingredients to a third party testing lab for a second opinion (we do all tests required by the FDA and their posted cGMP guidelines and then a few more for our own satisfaction before any ingredient goes into an Epionce product).
Question 3: Do you do skip lot testing? Or do you test every batch for quality and contaminants?
Every lot (whether raw material or finished product) is tested. We also perform some additional tests a skip lot basis at various time points through the life of our products as a secondary check against our already stringent QA standards.
Question 4: What is your rejection rate on raw materials?
Considering that we only purchase our raw materials from high quality, well respected sources, our rejection rate is VERY low. So far this year we have rejected less than 1% of the materials we have purchased and 60% of these rejections were from shipping damage or something other than a quality problem with the actual ingredient itself.
Question 5: How do you keep up with Economically Motivated Adulterants?
As mentioned above, the first line of defense against EMAs is to never buy from the multiple discounter sources that are out there. A lot of the ingredients we purchase are also available from discounted sources, but, unlike some less than honorable manufacturers in our industry, we are not motivated by cost savings and are not trying to maintain our stock market value, etc. We are only motivated by quality and efficacy. This is one of the main reasons we will never use a 3rd party manufacturer to make our products… All of our vendors must be members in good standing of certain trade organizations that hold their members to very exacting standards.
In addition, we use pharmaceutical grade ingredients whenever possible which are manufactured under far more scrutiny of the FDA than even we are. Keep in mind that adding EMA’s is fraudulent and illegal and would require the falsification of the affidavit C of A that accompanies every ingredient. Our in house testing would pick up on adulterants as would any of the QA departments of our honorable competitors. The result to the supplier if they tried this would be devastating to the point of being unrecoverable. Reputable suppliers would not risk this and reputable skin care manufacturers will not risk buying from non-reputable suppliers.
