Chemular - Regulatory Compliance Experts

Liquid Bones US


Liquid Bones US

The US FDA requires that manufacturers provide “a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of e-liquids and aerosolizing apparatus.”

Manufacturers are required to maintain and submit SOPs and forms to enable FDA to more fully understand the methods used in, and the facilities and controls used for, the manufacturing and processing of the e-liquid and e-cig, including a description of facilities and all production steps, managerial oversight and employee training, manufacturing processes and controls for product design, including a hazard analysis that details the correlation of the product design attributes with public health risk, and any activities related to identifying and monitoring suppliers and the products supplied (including, for example, purchase controls and materials acceptance activities), validation and verification activities used to ensure that the new tobacco product matches specifications, including a description of acceptance activities with protocol and acceptance criteria, handling of complaints, nonconforming products and processes, and corrective and preventive actions.

Liquid Bones US provides all of the SOPs and forms the US FDA requires e-liquids and e-cig manufacturers to establish and maintain, including:

  • Calibration 
  • Clean, Sanitary and Safe Preparation of Products 
  • Control of Documents 
  • Control of Nonconforming Product 
  • Control of Records 
  • Corrective and Preventive Action 
  • Design and Development 
  • Equipment Validation 
  • Gowning and Entering the Manufacturing Floor 
  • Identification and Traceability 
  • Internal Auditing 
  • Management Review 
  • Packaging and Labeling Standard 
  • Preservation of Product 
  • Preventive Maintenance 
  • Purchasing 
  • Recall 
  • Receiving 
  • Risk Analysis 
  • Shipping 
  • Training Procedure
  • Vaping Products Monitoring and Testing 


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