Remote Inspections, Self-Inspection Checklist, and Other Updates for Cannabis Manufacturers in California
June 24, 2020
by Tiffany Carrari, Associate Transactional Attorney
On June 5th the California Department of Public Health’s (CDPH) Manufactured Cannabis Safety Branch (MCSB) issued an update detailing MCSB’s current operations in light of California’s COVID-19 Stay at Home order. The update also contained information for l icensees including reminders about Good Manufacturing Practices (GMPs) and Sanitary Practices, including guidance from the Centers for Disease Control and Prevention, Cal/OSHA, and a fact sheet about Cannabis Product Safety During COVID-19; information about license fee deferrals and how to request regulatory relief, as well as the MCSB’s form for requesting regulatory relief; tips for securing licensed premises from theft; and instructions for the MCSB’s theft notification procedures.
In addition, the MCSB announced that in an effort to facilitate COVID-19 social distancing mandates, some of their inspections are being conducted remotely. In order to help prepare licensees for a remote inspection, the MCSB developed a checklist of major areas evaluated during a routine on-site inspection. The MCSB Self-Inspection Checklist can be accessed here.
Much of what is contained in the checklist are written operations documents that manufacturing licensees are required to submit or update as part of their application for licensure or renewal, as well as required to be kept onsite for ongoing compliance. Such written documents include the licensee’s Security Plan, Inventory Control Plan, Premises Diagram, Master Manufacturing Protocols and Product Quality Plans, Waste Management Plan, and Personnel Procedures. Subchapter 6, Article 4, §40200, §40282, §40105, §40255, §40253, §40290 and §40246 of the Manufactured Cannabis Safety Regulations contained in Title 17, Division 1, Chapter 13 of the California Code of Regulations (MCSB Regs).
If you are preparing for an inspection, you should make sure that these written documents are an accurate reflection of your real-life facility operations and that your real-life facility operations are compliant with MCSB regulations.
Security Plan/Video Surveillance – Make sure you video surveillance records 24/7 and that recordings are kept for 90 days. In addition, be sure that your cameras surveil all areas in which cannabis is stored or processed or through which cannabis is moved. §40200, §40205.
Inventory Management & Track-and-Trace – All cannabis items coming into, leaving from or held within your facility must be accurately recorded in track-and-trace, tagged with package tags, and immediately identifiable and locatable at all times. Transfers of cannabis products onto or off the manufacturing premises must only be conducted by a licensed distributor using a transfer manifest and your on-site inventory needs to be reconciled with track-and-trace every 30 days. §40282, §40510-40517.
Premises Diagram – The premises diagram on file with MCSB must accurately reflect the current layout of your premises. §40105.
For Operations with Closed-Loop Extractions – Your operation’s extraction unit must be engineer certified as properly installed and the extraction system, solvents and operation must be up to code and approved by the local fire official. Also, the extraction area must be ventilated and operated in accordance with Cal/OSHA regulations. There must be written procedures that are followed for training operators and system maintenance, as well as documented maintenance logs. §40222, §40225.
For Operations using Non-Volatile Solvent Extractions – Ethanol extraction operations must have been approved by the local fire code official and Cal/OSHA compliant. Be sure that all solvents have been disclosed and approved by MCSB and that any non-hydrocarbon solvents are food grade. §40220, §40223.
Master Manufacturing Protocols – For each unique formulation of cannabis product, you must have a written Master Manufacturing Protocol (MMP) that includes step-by-step instructions, ingredients and weights, cannabinoid concentration and packaging/labeling information. §40255.
Batch Production Records – For every batch of cannabis product manufactured, there must be a record documenting each step (initialed by the person who took it) in the production process that matches up to the MMP for that product. The record shall also document the batch/lot number and UIDs of the finished product, UIDs of all cannabis ingredients, and any batch/lot ID for non-cannabis ingredients. §40258.
Product Quality Plan – You must, for each type of product, identify and evaluate biological, chemical and physical hazard risks, as well as mitigation methods and prevention monitoring. §40253.
Good Manufacturing Practices – Make sure your facility, fixtures, equipment and utensils are properly used, well maintained, as well as cleaned and sanitized in accordance with written procedures and maintenance logs. Cannabis and other ingredients must be properly stored and held at appropriate temperatures, with major food allergens identified and stored to prevent cross-contact. §40230, §40248.
Personnel – A written Disease Control Plan must be in place to mandate self-reporting of illnesses or open lesions by employees (who shall be kept out of contact with manufacturing areas). The plan must further provide for personal protective equipment (PPE), when needed, as well as hand washing protocols, delineated areas for personal items such as food and drink, and safety training. §40246.
Weights and Measures – Your weighing devices must be approved, tested and sealed by the county sealer and a licensed weighmaster must perform weighing, measuring or counting of commercial cannabis products. §40277.
If You’re Packing & Labeling Finished Goods – Your packaging must be child-resistant, tamper evidence and opaque. Your primary label must identify the product and display the universal symbol, and your informational panel must include the UID and batch/lot number, licensee information, ingredients and allergen warning (if applicable). Further, the innermost product containers must bear the universal symbol and there shall be no health claims made. Nor shall the label be designed to be attractive to children. §40403, §40417.
Waste Management – Your cannabis waste must be rendered unusable and unrecognizable, and held in a secured area until picked up or self-hauled. For cannabis that is picked up, you need to maintain documentation and contact information for the waste hauler. And if you self-haul, you need to keep a weight ticket/receipt from the waste facility. §40290.
Possible Remote Inspections- The MSCB has not indicated which operations will be eligible for remote inspection, but has stated that if you are due for an inspection (and eligible), a MCSB team member will let you know. Presumably, routine inspections of already-licensed facilities for whom renewal applications are being processed are among the likeliest “eligible” candidates. Also, please note the MCSB is still doing onsite inspections when a physical presence is “needed” (read: If the MCSB is investigating an alleged violation, you might be getting a masked visit).
In the event your operation is due for an inspection, and the MCSB chooses to do it remotely, you will first be asked to complete a questionnaire and e-mail pertinent facility and operations records to the inspector. The inspector will the follow up by asking for additional documentation as needed, and may even engage on a video call as part of the inspection.
If your manufacturing operation is due for an inspection and you need help to prepare, please contact our office. We can assist with verifying or bringing you into compliance so that your onsite or remote inspection goes off without a hitch!
This information is provided as a public educational service and is not intended as legal advice. For specific questions regarding MCSB inspections or other topics related to cannabis or hemp, please contact the Law Offices of Omar Figueroa at info@omarfigueroa.com or 707-829-0215 to schedule a confidential legal consultation.