Order to Cease Manufacturing to a Sperm Donor

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.

  1. Margaret Hamburg, FDA Commissioner
    Click to e-mail her directly: margaret.hamburg@fda.hhs.gov
     
  2. 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
     
  3. 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
     
  4. Outside of California:  Below is a link to Senators for all 50 states:
    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. 

     

Copies of the above referenced material:

FDA Order to Cease Manufacturing - 01-Nov-2010
online at http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/TissueSafety/ucm232852.htm
 


Page 1 (PDF)

Page 2

Page 3

Page 4

Page 5

A PDF of this same document is available here: FDA-order-to-cease-manufacturing-trentdonor-2010-1101.pdf 
 

Letter to FDA Commissioner - 28-Nov-2010


Page 1 (PDF)

Page 2

Letter to CBER Compliance (PDF)


 

Reply to Cease Manufacture / 486 Response 01-Nov-2010


Page 1 (PDF)

Page 2

 

Inspection Observations 20-Sep-2010


Page 1 (PDF)
 

 

Signed Affadavit 17-Sep-2010


Page 1 (PDF)

 

Request for Extension to Reply 01-Oct-2010


(PDF)

(PDF)