Well it's official, ABH Nature’s Products, Inc., ABH Pharma, Inc., and StockNutra, Inc. (ABH) issued a recall for all products manufactured for the past 7 years. A staggering 859 brands are included in the recall. Each of these 859 brands must now in turn issue a recall for the products that were manufactured by ABH during that period. The scale of this is mind-blowing; how will the FDA police this, there are just so many brands and products. My guess is plaintiffs’ attorneys are already lining up to start class action suits. This could get very ugly.
DILIGENCE vs. NEGLIGENCE
It was the responsibility of all 859 brand owners to do due diligence and ensure that ABH was manufacturing compliant to CFR 111 cGMP standards prior to engaging their services. It was also their responsibility to audit ABH on an ongoing basis. Audits should include site inspection, review of SOPs and training logs, review of Master Batch Records prior to approving initial production runs, review of Batch Production records and corresponding backup documents for ongoing batches including raw ingredient testing. In addition, a review of prior CFR 111 audit documents, prior 483s and Warning Letters along with corrective actions should be done. This is not a complete list but a good part of what a due diligence cGMP audit would entail.
This is important: you cannot rely on the contract manufacturer's (CMO) test results; you must test a random sample of the finished product after it is delivered to your warehouse. ABH was accused by a brand owner of using “by input” on their test results which, if true, means the product wasn’t even tested, they just listed what the dose was supposed to be on the COA. Let me be clear, I am by no means attacking CMOs, there are excellent ones out there that are fully cGMP compliant. Verification is just smart business and will over time help you weed out the good from the bad while protecting your brand equity along the way.
Brands choosing a (CMO) should view this as a case study for how to quickly disqualify a CMO. In this case, a simple Google search would have been sufficient due diligence to realize there was a serious problem. Multiple 483s and Warning Letters going back to 2012 showed up. Apparently their NSF certification was pulled. There are customer’s accusations ranging from fake test results to fake products. Here is a scary quote from a brand owner: "My guess is that they are picking random small companies to scam. I believe that they are accepting an order, creating 1 or 2 bottles of the real product to keep as their “retained sample” and then shipping the customer a batch of placebo pills that they bottle as the real product."
Each of these on their own may be insignificant but viewing the totality prior to site inspection and audit should have raised a red flag. I just got off the phone with a friend who is a consultant who called me for my opinion on regulatory issues. He’s having a hard time getting a CMO to turn over documents to his client. The CMO excuse: “well none of our other clients asked for it, so it’s not required.” I can see ABH saying something similar to each of their clients right up to #859, “well none of our 858 clients have ever asked for documents, why do you need them?"
When it comes to quality and regulatory issues, the absence of due DILIGENCE is NEGLIGENCE. Trust me, you don't want to be in the position of the ABH 859. Don't wait for an FDA auditor, a class action jury or your own customer to prove me Right.
