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Quality & Compliance

Leveraging our FDA-inspected and registered facility, our operating standards are pharma-compliant for quality and manufacturing in the current unregulated e-Liquid industry.

  • Raw materials tested to US Pharmacopeia standards or applicable standards as required
  • All incoming material quarantined and tested
  • Finished product tested for stability, microbial & impurities
  • Click here for HPLC sample
     
  • Product consistency and purity validated
  • Process is consistent and repeatable
  • Lot traceability and Certificate of Analysis (CofA) issued
  • Nicotine levels are “as listed” and validated
  • Facility is controlled and specifically designed for pharmaceuticals
  • All activities meet cGMP standards
  • HEPA Filtration / Positive Air Flow

FDA Registration Pharmaceuticals:  961871501
FDA Registration Medical Devices:  3008062657

Finished Product:

  • Testing includes microbial and impurities by lot
  • Records retained documenting all product batches meet label claims
  • Products have up to a 2-year expiration date (Axcentria stability and shipping studies)
  • Analytical services are available for Customers
  • Testing your products for label content accuracy, purity and stability
  • Designing Methodologies to resolve your issues and support your requirements
  • Click here for Certification of Analysis sample

cGMP
Refers to the current Good Manufacturing Practice regulations devised by the FDA which require that manufacturers, processors and packagers of drugs, medical devices and some foods and beverages take proactive steps to ensure that their products are safe, pure and effective.

Purity Pledge
We proudly source and validate with our Supplier Qualification procedures all our raw ingredients for the highest level of safety, purity and quality.

Made in the USA
When it’s made In the USA by Axcentria, our clients can be assured the highest quality products and approved manufacturing process were used to make their products.