Order to Cease Manufacturing of Semen to a Sperm Donor

Submitted by: trent on Feb 8, 2011 - (Last updated: Dec 16, 2011)

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)
Current	Awaiting decision from FDA Commissioner

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.