Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
failing to adequately screen “for disease risks associated with
xenotransplantation and Creutzfeldt-Jakob disease.” 117 Despite Arsenault
being tested seven times in less than four years, the FDA asserted that the
“testing of communicable disease agents were not collected at the
appropriate time.” 118 When the donations were handed over to recipients,
the “HCT/P’s were not accompanied with the summary of the records used
to make the donor-eligibility determination.” 119 The FDA also told
Arsenault that his “firm has not developed written procedures related to
testing, screening, and determining donor eligibility of semen.” 120
After being informed that his “firm” had failed to comply with 21 C.F.R.
Part 1271’s various obligations, Arsenault requested a time extension to
respond. 121 The FDA informed him that he was welcome to respond to the
observations report if he did so within fifteen working days of its issuance,
but that the FDA could proceed with an enforcement action without
considering any responses received after that deadline. 122 Arsenault, still
lacking legal counsel, was unable to respond in time.
On November 1, 2010, the FDA’s Center for Biologics Evaluation and
Research (CBER) issued an “Order to Cease Manufacture” to Trent
Your firm, Trent Arsenault (or Establishment), located at 38068
Canyon Heights Drive, Fremont, California, recovers and
distributes semen and therefore is a manufacturer of human cells,
tissues, and cellular and tissue-based products (HCT/Ps). The Food
and Drug Administration (FDA or agency) conducted an
inspection of your Establishment between August 27 and
September 16, 2010, and at the conclusion of the inspection, the
FDA investigator issued you a Form FDA- 483, Inspectional
Observations. Our review of the information and records examined
and collected during the inspection revealed significant violations
of Title 21, Code [of Federal Regulations, Part 1271 (21 C.F.R.
Part 1271) issued under the authority of Section 361 of the Public
Health Service Act (PHS Act) [ 42 United States Code (U.S. C.)
117. Id. at 2.
119. Id. at 4.
121. Trent Arsenault, Letter from Trent Arsenault to FDA (Oct. 1, 2010), available at
trentdonor-01-oct-2010-1-page.pdf (requesting more time to reply).
122. Trent Arsenault, Letter from FDA to Trent Arsenault (Oct. 7, 2010), available at
trentdonor-07-oct-2010-1-page.pdf (encouraging a partial response from Mr. Arsenault as
soon as possible).