The April 16, 2020, FDA warning letter to Greiner Bio-One North America Inc., of Monroe, N.C., cited the manufacturer of Vacuette brand blood collection tubes for eight deviations from the Quality Systems Regulations (QSRs), including an alleged failure to qualify a new vendor for materials used in Greiner’s production line. Greiner responded twice to the inspectional findings from the December 2019, inspection, but the FDA said the adequacy of those responses could not be evaluated as of the date of the warning letter. A citation under complaint handling noted that company records included instances of “caps popping off tubes” in a June 2019 complaint, for which Greiner had opened a corrective and preventive action report, but again, the FDA was unable to assess the adequacy of the proposed corrective action. In a citation for finished device acceptance, the FDA said the company’s procedures had deviated from ISO 6710, a standard for test methods for single-use venous blood specimen containers. The warning letter also cited Greiner for failure to submit a medical device report (MDR) in connection with a complaint that a venipuncture device experienced needle disconnect from the holder hub. The FDA recall database lists three class II recalls of Vacuette tubes and transfer units, but each of them is dated after the date of the inspection.
The U.S. FDA said that the applicable regulatory review period for the i-Stent trabecular micro-bypass system by Glaukos Corp., of San Clemente, Calif., is 2,508 days of which 178 days were consumed during the regulatory review phase. The FDA was responding to the U.S. Patent and Trademark Office, which undertook a review of the patent term extension application by Glaukos for two patents related to the i-Stent, and said the sponsor seeks as many as 1,783 days of patent term extension. Parties who wish to dispute these dates may contact the FDA by Sept. 13.
The U.S. Federal Trade Commission said it and Ortho-Clinical Diagnostics Inc., of Raritan, N.J., have come to terms over allegations the company misrepresented its participation in the EU-U.S. Privacy Shield Framework. The FTC said the company had allowed its certification to lapse in 2018, although the press release did not describe the duration of the company’s misrepresentative claims about participation in the framework beyond the lapse date. The FTC statement does not cite any financial penalties, but said Ortho-Clinical was forbidden from misrepresenting its participation in this and other privacy agreements.