$120,000 Fine: Selling Vaporizers Containing Excessive Levels of Ethanol
Revolutionary Clinics was fined $120,000 for selling tainted marijuana vapes to settle charges it sold vaporizers containing excessive levels of ethanol to six other dispensaries, several of which then sold dozens of the tainted devices to consumers.
Revolutionary Clinics operates medical dispensaries in Cambridge and Somerville and also has a cultivation and processing facility in Fitchburg, said the problem occurred when a former employee failed to read the full set of results from required laboratory tests on the affected vapes. (The worker was subsequently fired, and the lab involved now includes failing results on the first page of its reports, according to a commission report on the investigation.)
The chemical, in this case, was leftover from a solution Revolutionary Clinics used to clean its processing equipment. This is why Good Manufacturing Practices is so important to learn from when setting up an operation. A great reference area is FDA GMP 111 Standards, they may look intimidating but worth the read and compare your operations to what is expected of a dietary supplement manufacturer. You can learn about the different GMP programs even those geared towards Drug GMP at FDA Resource Site.
ndrew Carter, the commission’s associate enforcement counsel, said Thursday that the vape cartridges at issue contained 5,500 to 9,000 parts per million of ethanol, while the state limit is 5,000 parts per million.
Revolutionary Clinics first shipped the vapes to a wholesale customer in December 2018, but the contamination was detected by the cannabis commission in March 2019. That’s when the flunking lab results were uploaded to the state’s then-new “seed-to-sale” software system, which tracks each regulated cannabis product and which plants were used in its manufacture.
According to the commission report, Revolutionary Clinics at first said the vapes had been sold to just two other licensed cannabis operators, Pharmacannis and Patriot Care. In reality, the devices had also been shipped to Hope Heal Health, Good Chemistry, Triple M, and Mass Wellspring — a fact the company failed to disclose until a meeting with investigators in September.
Why hide anything from investigators, oftentimes we advise our clients to self-report issues that have happened internally, it can strengthen the relationship with the regulatory body.
The 5 Key Componets of a Good GMP Practice
GMP helps to ensure the consistent quality and safety of products by focusing attention on five key elements, which are often referred to as the 5 P’s of GM
People– Have clear roles and responsbilities defined, ensure they are following all procedures and ensure they are trained and assessed for the work they do.
Premises and Equipment– Design to allow for effective celaning and preven cross-contamination.
Processes– Are clearly defined, consistent and documented. Are validated and calibrated, have procedures, schedules and records.
Products– Have specifications for raw materials, compoinents, intermediate and finished product. Follow methods for manufacture and packing, testing, sampling, status control, stability testing and records.
Procedures (or paperwork).– are clearly defined, consistent and documented. Have critical steps identifed and have robust change control processes.