FDA orders New York Fertility Institute to Cease Manufacturing of HCT/Ps - Mothering Forums
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#1 of 1 Old 03-14-2013, 02:26 AM - Thread Starter
 
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I haven't studied the issues around fertility treatment in depth, but this link arrived as part of one of my FDA mailing-list subscriptions and I thought it might be of interest to some of the MDC readership.

 

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/TissueSafety/ucm342671.htm

 

Excerpt:

 

 

Quote:
Our review of the information and records examined and collected during the inspection revealed significant violations by New York Fertility Institute of Title 21, Code of Federal Regulations, Part 1271 (21 CFR 1271), issued under the authority of Section 361 of the Public Health Service Act (PHS Act) [42 United States Code (USC) 264].  The agency has determined that because your Establishment is in violation of 21 CFR Part 1271, your Establishment does not provide adequate protections against the risks of communicable disease transmission through the use of these HCT/Ps [human cells, tissues and cellular and tissue-based products]. The agency has also determined that there are reasonable grounds to believe these violative HCT/Ps pose a danger to health, and, accordingly, this Order to Cease Manufacturing is effective immediately.  This Order to Cease Manufacturing relates to conduct occurring on or after May 25, 2005, the effective date of the applicable regulations and applies only to HCT/Ps from anonymous and directed donors.
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