Jul. 31, 2025 – Great News
This week, 2 FDA Consumer Safety Officers (CSOs) conducted a routine CGMP inspection at our company, BioPharmaDev, Inc. (a CRO company providing third-party high-quality analytical testing services for pharmaceutical, Biotech, medical device, and nutrition supplement companies). We are very happy to announce that the FDA CSOs did not issue a Form FDA-483 as a result of the inspection. This indicates we have no deficiencies or no any Inspection Observations. Our facility is at the best cGMP compliance classification of No Action Indicated (NAI) as defined and published in the FDA’s Inspection Classification Database.
We are very proud of ourselves for this excellent achievement. This is the 3rd FDA inspection since the beginning of our business in 2012. The first FDA’s inspection was in 2017 with one minor observation. The 2nd FDA’s inspection was in 2018 with no observation or deficiency.
We sincerely thank Dr. Yan-Bo Yang, Dr. Gary Xu, Dr. Mai Zhou, and Mrs. Yan Zou for their hard work and dedication. Most importantly, we thank many of you (our family members, our dear friends, and our clients) for providing long-term support, making great contributions and providing help. This could not happen without your involvement.
Apr. 22, 2020 – Dr. Yan-Bo Yang is a member of the planning committee for the 2020 Prescription Non/Prescription (PNP) Stakeholder Forum.
Nov. 19, 2018 – We would like to share with our elite clients that we received the letter from the FDA today that the inspection conducted in August 2018 was closed with a “No Action Indicated (NAI)” classification. An FDA website search result is also attached. We sincerely thank our clients for your support and for the opportunity of doing business with us.
Aug. 23, 2018 – We are very happy to announce that today we successfully completed and passed another FDA cGMP inspection with no 483 (i.e.: 0 deficiencies). It was an inspection from the US FDA with no pre-notification. This verified our high-quality standards and status. We are very proud of this result.
Mar. 3, 2018 – Dr. Yan-Bo Yang is invited as a member of the USP General Notices Revision Project Team.
July 21, 2017 – Dr. Yan-Bo Yang co-authored an editorial article in the Journal of Molecular and Applied Bioanalysis
August 2016 – AOAC INTERNATIONAL published ALACC Guidelines – An Aid to Interpretation of ISO/IEC 17025:2005. Dr. Yan-Bo Yang was one of the key contributing leaders.
Jul. 26, 2015 – Dr. Yang received an Official Methods Board (OMB) Award for Achievement in Technical and Scientific Excellence from AOAC
Jul. 22, 2015 – ALACC Guidelines Revised; To Be Published August 2015
Mar. 7, 2014 – Project Team Member for revising USP General Notice (USP 39 – NF 34)
Dec. 23, 2013 – FDA registration renewed for 2014
Oct. 14, 2013 – Dr. Yan-Bo Yang appointed as Chair of ALACC Dietary Supplements Subcommittee of AOAC INTERNATIONAL
Aug. 7, 2013 – FDA registration completed
May 15, 2012 – Chaired USP PNP Stakeholder Forum