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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 |
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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 |
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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 |
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Affadavit Page 1-5 (JPG) Page 1-5 (PDF) |
Sep, 20, 2010 | FDA issues Form 483 - Inspection Observations |
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FDA Form 483 Page 1-5 (JPG) Page 1-5 (PDF) |
Oct 1, 2010 | Letter sent to FDA requesting more time to reply |
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Page 1 (JPG) Page 1 (PDF) |
Oct 7, 2010 | FDA SF Office Replies to extension for more time |
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Page 1 (JPG) Page 1 (PDF) |
Nov 1, 2010 | FDA Issues Cease Manufacturing order |
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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 |
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Page 1-2 (JPG) Page 1-2 (PDF) |
Nov 8, 2010 |
Cease Manufacturing Order Date pending hearing decision at FDA Commissioner level |
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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 |
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Page 1-2 (JPG) Page 1-2 (PDF) |
Nov 28, 2010 | Letter to CBER Compliance |
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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 |
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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.
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Margaret Hamburg, FDA Commissioner
Click to e-mail her directly: margaret.hamburg@fda.hhs.gov
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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
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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
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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
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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
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![]() Letter to CBER Compliance (PDF) |
Reply to Cease Manufacture / 486 Response 01-Nov-2010
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Inspection Observations 20-Sep-2010
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Signed Affadavit 17-Sep-2010
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Request for Extension to Reply 01-Oct-2010
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