AUSTIN, Texas, July 22, 2021 (GLOBE NEWSWIRE) — via InvestorWIre — Beard Management Inc., the company behind multiple globally recognized e-liquid brands such as Beard Vape Co. and The One E-liquids, announced today that they successfully completed an inspection by the U.S. Food and Drug Administration (FDA) as a part of their PMTA application review on July 13 and 14.
The inspection reviewed the company’s current production and sales records, ensuring all products currently on the market follow FDA deeming laws. The agent also reviewed company documentation that proved all products contained in the PMTA filing were, in fact, widely distributed prior to Aug. 8, 2016. The company successfully completed the inspection with no written or verbal violations noted.
Beard Management Inc. is currently in the review phase of their PMTA application, which includes 45 of their most popular e-liquid products, including flavors from their Beard Vape Co. and The One E-liquid brands. In April of this year, Beard announced that Blackbriar Regulatory Services, LLC (BRS) had been retained as their exclusive manufacturer and agent of record with the FDA, overseeing the process of providing the FDA with any additional regulatory and testing work required for Beard’s current PMTAs to scientifically prove its products are appropriate for the protection of public health. In that capacity, BRS had a team of regulatory experts on-site at Beard’s Austin facility to assist during the July FDA inspection.
“We are excited and honored to be part of Beard’s production and regulatory team as we help them navigate the turbulent waters of the FDA audit and regulatory process,” said Jason Krull, Director of Quality for BRS and one of the BRS team members on-site for the inspection. “Through this partnership and diligent preparation by both the BRS and Beard teams, we were able to provide all the necessary documentation to the FDA without incident, making the audit process a smooth one for our customer.”
“This inspection absolutely reaffirms our decision to use BRS for our regulatory needs,” said Brady Bates, CEO of Beard. “Over the past few months, we have worked with them to prepare for the eventuality of an inspection like this. Thanks to BRS’ in-depth understanding of the PMTA review process and their experience in dealing with FDA inspections, we were very well prepared for what transpired. The successful completion of this inspection further strengthens our market position, our application and our positive relationship with the FDA, and we couldn’t be happier with the outcome.”
About Beard Management Inc.
Beard Management Inc. owns and distributes numerous brands across varying categories, including electronic nicotine delivery system products, hemp derivatives and rolling papers. Founded in 2014, Beard remains committed to continuous product development while providing high-quality products to adult consumers. Beard currently services retailers and distributors of every size nationally and in over 30 countries worldwide. To learn more about Beard, go to www.beardvapeco.com.
About Blackbriar Regulatory Services
Blackbriar Regulatory Services specializes in helping small to mid-sized domestic and international companies navigate the regulatory landscape to bring their U.S. Food and Drug Administration (FDA) regulated product concepts to market. Since its inception, BRS has perfected processes in cost-efficient
manufacturing, analytical testing, regulatory compliance audits and filings, rigorous project management, packaging design and product stewardship for international customers from the United States, Europe and Asia. BRS prides itself on speed and flexibility while never compromising quality or its customers’ confidential information. Learn more at www.bb-rs.com.