Rapid Therapeutic Enters Contract for Certified Lab for Manufacturing Consistent with FDA Rules
Dallas, TX – June 30, 2020 – Rapid Therapeutic Science Laboratories, Inc. (OTC: RTSL) an SEC fully-reporting, growth-oriented company focused on manufacturing and marketing aerosol delivery systems based on pressurized Metered Dose Inhaler (MDI) technology, announced today that it has executed a contract leasing a new state-of-the-art laboratory. The laboratory is being certified for manufacturing under Food and Drug Administration (FDA) rules.
Rapid Therapeutic Science Laboratories, Inc. Chairman and CEO, Donal R. Schmidt, Jr. stated, “We are extremely pleased to announce the Company has leased a state-of-the-art lab tested to ISO 6 standards. This lab will allow us to immediately pursue RTSL’s stated goal of FDA registration of all RTSL products. RTSL will immediately begin manufacturing according to ISO 13485 standards for medical devices.” https://www.iso.org/iso-13485-medical-devices.html. https://www.iso.org/standard/59752.html. The FDA adopted this standard in 2018. https://www.iso.org/news/ref2318.html.
Sean Berrier, Sr. VP and Co-founder commented: “RTSL will not maintain the lab as a certified “clean room,” instead the Company maintains general facility/process controls in its environmentally filtered operations, as part of compliance with FDA Good Manufacturing Practices (GMP) related to ISO 13485. Nevertheless, RTSL will periodically perform random testing to assess initial set-up, filter functional efficacy, personnel gowning consistency, and general process stability. Under ISO 13485 the lab rooms will function as “control rooms.” The goal is to organize layout, and minimize overhead particulate matter, thereby optimizing process flow and reducing product fallout. This allows for RTSL to manufacture a class II medical device under GMP. We believe we are one of only a handful of companies manufacturing CBD consumer products with this level of sophistication. This lab gives our clients a high level of assurance that our products are safe and clean with no adulterations.”
About Rapid Therapeutic Science Laboratories, Inc. (OTC: RTSL)
RTSL is an aerosol manufacturer which has developed and perfected a new method of formulation and manufacturing to deliver pure CBD, CBG and/or THC and combinations thereof in legal jurisdictions to consumers through an FDA approved medical device known as a pressurized Metered Dose Inhaler (pMDI or MDI). The Rxoid MDI product line is manufactured in compliance with GMP on FDA approved equipment. Non-THC Cannabinoids are not yet approved by the FDA but are legal to consume in TX and many other states and export to legal foreign jurisdictions.
A MDI is a replacement for vape pens, as it uses no heat and needs no dangerous ingredients to work. In addition, MDIs are less expensive than any other route of delivery measured by blood serum levels. They are however expensive to formulate and manufacture so that they legally and properly work as an MDI under FTC rules on truth and labeling.
RTSL markets its RxoidTM MDI products directly to pharmacies and physicians who treat GAD, PTSD and other stress and anxiety disorders.
RTSL’s MDI products also can be purchased by consumers online at www.rxoid.com.
We encourage all customers to do their own research regarding cannabinoids, the use of MDIs and our products. RTSL makes no claims about therapeutic benefits of its products. None of our products are intended to diagnose, treat, cure or prevent any disease. Always consult a physician prior to using any cannabinoid product. If you experience any adverse reaction stop use immediately and seek appropriate medical attention. RTSL’s products are not approved by the FDA or under the Food Drug & Cosmetics Act (FD&C Act).
Visit our corporate website at www.rtslco.com.
This press release may contain forward-looking statements. In particular, when used in the preceding discussion, the words “may,” “could,” “expect,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “likely,” “will,” “would” and variations of these terms and similar expressions, or the negative of these terms or similar expressions are intended to identify forward-looking statements. Any statements made in this news release other than those of historical fact, about an action, event or development, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors, which may cause the results of RTSL, its divisions and concepts to be materially different than those expressed or implied in such statements. These risk factors and others are included from time to time in filings made by RTSL with the Securities and Exchange Commission, including, but not limited to, in the “Risk Factors” sections in its Form 10-Ks and Form 10-Qs and in its Form 8-Ks, which we have filed, and file from time to time, with the U.S. Securities and Exchange Commission. These reports are available at www.sec.gov. Other unknown or unpredictable factors also could have material adverse effects on RTSL’s future results and/or could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements. The forward-looking statements included in this press release are made only as of the date hereof. RTSL cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. We undertake no obligation to update publicly any of these forward-looking statements to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable laws. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.
Donal (Don) R. Schmidt, Jr.
Chairman and CEO
Source: Rapid Therapeutic Science Laboratories, Inc.