BIOLabs PRO - Manufacturing information/ Legality

  1. Shyne Brands, LLC, the parent company for BIOLabs PRO® was founded in 2016.  Our manufacturing company is registered with the FDA and with the Arizona Board of Pharmacy and its GMPs were last audited by the FDA in November of 2017. The Arizona Board of Pharmacy GMP audit was in January of 2018.
  2. We are in full compliance with 21CFR211. That is the standard required of us by our FDA registration to manufacture dietary supplements, OTC drugs and cosmetics. It is also the GMP standard required of us to manufacture prescription drugs by the Arizona Board of Pharmacy. 
  3. Our board of pharmacy registration entitles us to manufacture prescription drugs for sale to hospitals, pharmacies, doctors and distributors who are registered with the FDA and the DEA to distribute drugs.
  4. We are registered with the USDA and audited by Natural Food Certifiers (NFC) to manufacture organic products and kosher products. 
  5. We manufacture our own products in our FDA inspected facility located in Phoenix, Arizona.  Our main administrative office is located at, 701 Palomar Airport Rd, Suite 170, Carlsbad, CA, 92011.
  6. Our incoming raw materials go into a quarantine area until they are inspected and released into production by our QC department. All manufacturing is in accordance with the GMP standards detailed in 21CFR211. This includes documenting all batches and testing of the finished products before they are released to our customers. 
  7. Our manufacturing equipment is cleaned and sanitized between every batch or daily, whichever comes first. Every CofA on raw material is verified independently several times before our company will accept as valid a vendors CofA.
  8. When a preservative is necessary we often use, Herbal-Active®, a proprietary blend of essential oils and herbs that has been shown to be highly effective as a natural preservative. In accordance with FDA regulations we sometimes refer to this as a natural flavor. Typically, the percentage used ranged from 0.2% to 0.5%, depending on the product.  .
  9. Our formulators include doctors, chemists and highly experience staff. This team have a track record over 25 years of formulating and developing products starting with Life-flo Health Care Products, a company later sold to Nutraceutical Corp of Utah.  Testing is conducted by approved third party labs and includes micro testing and assays to ensure efficacy. All of this testing is in accordance with our standard GMP protocols. 
  10. Our QC sets the standards based on our SOPs which are in accordance with 21CFR211. The individual raw materials are tested independently to ensure conformance with their CofA as submitted by our raw material vendor and then the finished products is submitted to an independent FDA approved lab for Micro Testing and Assay to ensure the product specification has been met.
  11. Upon request we can provide you with copies of our Third-Party Microbiological Certificate of Analysis provided by Micro Quality Labs, INC, which tests every batch for TPC, Yeast/Mold, E.Coli, S.aureus, and Salmonella/Shigella.
  12. Upon request we can provide you with copies of our Analytical/Chemical Certificate of Analysis also provided by Micro Quality Labs, INC.  This report is a test for the exact amount of primary or active ingredient in each BIOLabs PRO product.  These tests are conducted quarterly and the primary/active ingredients often come in right at the exact amount or higher than advertised on our labels.
  13. The shelf life of all of our products have been tested to 2 years. A typical lot number and expiry date on our products will read as follows: 180525TP04-20. This code is decoded as follows: 18 = year of manufacture, 05 = month of manufacture, 25 = day of manufacture, TP = product code and product expiry = 04-20.
  14. We have $3 million of product liability insurance and we can issue you a Certificate of Insurance immediately and at any time that covers you against any claims on products that we make.