Far East Summit recognizes its responsibility to the practitioner and the patient to provide safe and effective herbal products. Our Living Credo binds us to this responsibility. Far East Summit assumes responsibility at every level of the manufacturing process which is why all our products are inspected, manufactured and/or packaged in our company owned and operated, local and State licensed, FDA registered and cGMP certified manufacturing facility.
For millennia, herbs have been studied, used and honored for their healthful properties. Traditionally herbs have been organically cultivated or wildcrafted, but expansive industrialization over the past two centuries has radically changed the natural environment and the methods of cultivating, harvesting and preparing herbs.
Although modernization has greatly increased the productivity of farmers, herbs are now in constant danger while facing threats to their safety and efficacy from exposure to chemicals and manufacturing excesses such as industrial waste being released into the air and water and chemical pesticides and fertilizers used by farmers to promote better yields.
oday, Good Manufacturing Practices (GMPs) are government established guidelines that regulate the manufacturing process to assure raw material and finished product quality, safety and consistency. To ensure compliance and traceability every manufacturing step must be documented and adhere to its GMP defined guidelines. An individualized Standard Operating Procedure (SOP) guide allows a company to document their operations and substantiate adherence to GMP guidelines and, therefore, the safety of each and every batch of products.
In addition, our Quality Control unit approves and implements all procedures, specifications, examinations and tests that control the purity, quality and composition of ingredients and products. Our adherence to the established FDA cGMP regulations means complete documented evidence that ingredients, production batch & packaging records and laboratory tests are maintained and kept on file and that procedures are followed at each step of the manufacturing process assuring purity, batch-to-batch consistency, and the overall quality and traceability of all Far East Summit products from the finished product back thru bottling, production, receiving of raw materials from our suppliers.
To ensure finished products are safe and free of adulteration or contamination, the United States Food and Drug Administration has created a set of current Good Manufacturing Practice (cGMP) regulations. With the FDA cGMP regulations as a guide and using our expertise, Far East Summit has implemented and maintains a Standard Operating Procedure (SOP) manual which documents the steps, and extensive controls covering facilities/buildings, clean air/water, personnel training, sanitation, hygiene, utensils, equipment, production materials/containers, as well as testing specifications and limits for pesticides, microbial containments and heavy metal content.
A quality finished product begins at the source and, therefore, Far East Summit only associates with reputable and honorable vendors. We know our raw material suppliers share our responsible vision of safe and effective herbal products. We recognize and support vendors who work with local farmers and certified agronomists which operate under strict harvest and preparation standards that seek to insure raw material accuracy and purity. All raw materials received into our facility are kept in quarantine before entering our manufacturing queue. Materials are labeled with a unique receiving identification number, and a proper authorized signoff will substantiate that all written documentation is correct thus providing ease of tracking by all Far East Summit departments. Many Chinese herbs are treated with sulfur to give them an appearance of freshness allowing them to be stored and preserved in warehouses for, occasionally, extended periods of time before being sold. As a result, many have shown unacceptably high levels of sulfites. Our customers' well being is our first concern and Far East Summit makes every effort to support the supply of sulfite-free herbs in the industry by purchasing from vendors who work with a network of growers in China who are contracted to grow herbs naturally and package without sulfites. No raw herbal ingredient comes into our facility in powdered form. This allows every herb to be inspected for accuracy, as well as for quality and freshness using traditional organoleptic examination based upon our decades of combined herbal, purchasing & manufacturing experience and our library of reference materials.
Using the guidelines established by the cGMP regulations of the United States FDA, Far East Summit guarantees all testing and validation of finished product is conducted in the United States by independent FDA recognized laboratories, following the most current published methodologies assuring all analysis meet modern detection limits, are unbiased, and accurate. All Far East Summit products meet or fall below detection standards set by the American Herbal Products Association or the US Pharmacopoeia for:
Microbial contaminants: Aerobic Plate Count, Coliform, E. Coli, Salmomella, Staph aureus, Yeast, Mold
Heavy Metal content: Mercury, Lead, Arsenic, Cadmium
Far East Summit relies on its suppliers who provide written assurance that pesticides have not been detected on all raw materials entering our facility. As an additional precaution, on a regular basis Far East Summit randomly chooses finished products to be sent to an independent laboratory for testing to determine no pesticides have been detected. The list of chemicals and detection levels can be found here >>
Quality control extends to all packaging components as everything comes with full lot tracking, CoA documentation, and sourced from FDA-registered, cGMP-compliant vendor partners.
As a default, ALL our products are packaged in dark amber brown glass to provide the most effective barrier to heat & light exposure.
Each bottle is sealed in moisture-barrier packaging with full lot tracking, COA documentation, and are FDA-registered, cGMP-certified manufacturing compliant.