OSBP vs. Qualgen, LLC., #1-M-4255 / #1-B-4469 – Case No. 1408: Respondent agrees to pay a fine of $95.24 per count for a total of $100,000.00

OSBP vs. Qualgen, LLC., #1-M-4255 / #1-B-4469 – Case No. 1408: The Board was called to order by President Spoon to hear the case of Qualgen, LLC. Shaun Riney, Managing Director for Qualgen was present along with Attorneys, Beau Patterson and Greg Frogge. Assistant Attorney General, Brinda White presented the Board with the Complaint for review. The Respondent was charged with multiple violations of state and federal regulations and rules, including failing to conform to Federal Food, Drug, and Cosmetic Act Good Manufacturing Practices. Ms. White then presented the Board with an Agreed Order. If the Board accepts the Agreed Order, Qualgen would agree to the following: The Respondent would admit to guilt on Counts 1003, 1090, 1260-1269, 1406 and 1409-1460. The Responded denies guilt on Counts 53-669, 722-1002, 1057-1088, 1144-1175, 1228-1259, 1270-1353, 1407-1408. The Respondent neither admits nor denies guilt on the remaining counts. The Respondent would be placed on probation for five (5) years until June 15, 2021 and may appear after one (1) year (after June 15, 2017) to ask the Board that the probation be lifted. In determining whether to lift the probation, the Board may consider such matters as the following: (a) Semi-annual reports to the Board by Respondent Qualgen regarding compliance with applicable laws, regulations and standards; (b) Retention by Respondent of an independent third-party consultant to review, monthly, to assess Respondent Qualgen’s compliance with applicable laws, regulations and standards, and make recommendations to promote compliance and (c) The engaging in mock inspections to monitor and promote Respondent Qualgen’s compliance with applicable laws, regulations and standards. The Respondent agrees to pay a fine of $95.24 per count for a total of $100,000.00 which is due and payable in three installments, as follows: $50,000 on June 15, 2016, 25,000 on September 15, 2016 and $25,000 on December 15, 2016. The Respondent will agree to remedy all observations noted by the FDA in its Form 483. Any application by any current or future member (owner) of Qualgen for any license issued by the Board filed before June 15, 2021 shall be made to the Board and decided by the Board. Any application by Shaun Riney for any license issued by the Board for himself on any business entity in which he owns an interest filed before June 15, 2021 shall be made to and decided by the Board. The Respondent’s PIC shall attend a one-day (8 hour) law seminar during the years 2016 and 2017 in addition to the required fifteen (15) hours of CE. Motion was made by Dr. Justin Wilson and seconded by Dr. Greg Adams to accept the Agreed Page 9 of 9 Order. Motion passed on roll call vote.

source Oklahoma Board of Pharmacy June 2016 minutes