Order to Cease Manufacturing to a Sperm Donor

Submitted by: trent on Feb 8, 2011 - (Last updated: Dec 19, 2012)

Summary:
The cease manufacturing order was issued 01-Nov-2010 and is online at:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/TissueSafety/ucm232852.htm

Timeline:

Date	Event	Source	PDF/JPG Image
Aug, 2007	1st Baby Born	Pregnancy History
Aug, 2008	4th Baby Born	Pregnancy History
Apr, 2009	FDA requests registration		E-mail Printout Page 1 (JPG) Page 1 (PDF)
May, 2009	Voluntary registration indicated	Registration Form	Image (JPG)
Aug, 2010	10th Baby Born	Pregnancy History
Aug, 2010	FDA Inspection Begins - 4 visits to Fremont home		FDA Form 482 Page 1-8 (JPG) Page 1-8 (PDF)
Aug 2010	FDA Director indicates registration required for directed donor
Sep, 16, 2010	FDA requests a signed affadavit		Affadavit Page 1-5 (JPG) Page 1-5 (PDF)
Sep, 20, 2010	FDA issues Form 483 - Inspection Observations		FDA Form 483 Page 1-5 (JPG) Page 1-5 (PDF)
Oct 1, 2010	Letter sent to FDA requesting more time to reply		Page 1 (JPG) Page 1 (PDF)
Oct 7, 2010	FDA SF Office Replies to extension for more time		Page 1 (JPG) Page 1 (PDF)
Nov 1, 2010	FDA Issues Cease Manufacturing order		Cease Order Page 1-5 (JPG) Page 1-5 (PDF)
Nov 1, 2010	Reply to FDA Cease Manufacturing order, Hearing Request, and Reply to Form 483		Page 1-2 (JPG) Page 1-2 (PDF)
Nov 8, 2010	Cease Manufacturing Order Date pending hearing decision at FDA Commissioner level		Page 1 (JPG) Page 1 (PDF)
Nov 27, 2010	3 pregnancies reported during "baby rush". Recipients uncertain if Cease Order affects their families (baby's biological siblings)	Pregnancy History
Nov 28, 2010	Letter to FDA Commissioner pleading for consideration		Page 1-2 (JPG) Page 1-2 (PDF)
Nov 28, 2010	Letter to CBER Compliance		Page 1 (JPG) Page 1 (PDF)
Feb 07, 2011	FDA Motion to Deny Hearing and Issue Administrative Judgement		Page 1-15 (PDF)
Jul, 2011	13th Baby Born	Pregnancy History
Aug, 2011	First recipient to report a second pregnancy (sibling baby)	Pregnancy History
Nov 07, 2011	Brief filed to FDA indicating Constitutional / Supreme Court violation		Page 1 (JPG) Page 1-16 (PDF)
2011-2012	Awaiting decision from FDA Commissioner
Nov, 2012	18th Baby Born, 25th Pregnancy Reported	Pregnancy History
Dec 13, 2012	Telephone call from FDA indicating hearing before Commissioner is denied

To contact your Senator or the FDA Commissioner to voice a concern, e-mail info is listed below.

Margaret Hamburg, FDA Commissioner
Click to e-mail her directly: margaret.hamburg@fda.hhs.gov
Diane Feinstein, US Senator from California
a.) Click this link: http://feinstein.senate.gov/public/index.cfm?FuseAction=ContactUs.Emailme
b.) Choose Health as the Topic and fill out the form
Barbara Boxer, US Senator from California
a.) Click this link: http://boxer.senate.gov/en/contact/policycomments.cfm
b.) Choose Health or Women's Issues as the Topic and fill out the form
Outside of California: Below is a link to Senators for all 50 states:
http://www.senate.gov/general/contact_information/senators_cfm.cfm

If you are not from California, couples anywhere in the USA could be affected, because the cease manufacturing of semen is based on federal law.