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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Seattle Sperm Bank, LLC 7/15/11

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

Seattle District 

Pacific Region

22201 23rd Drive Se

Bothell, WA 98021-4421

Telephone: 425-486-8788

FAX: 425-483-4996 

July 15, 2011 

 

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

 

In reply refer to Warning Letter SEA 11-19

 

Gregory M. Moga, III, Owner

Seattle Sperm Bank, LLC

4915 25th Avenue Northeast, Suite 204

Seattle, Washington  98105-5668

 

WARNING LETTER 

Dear Mr. Moga:

 

The Food and Drug Administration conducted an inspection of your firm, located at 4915 25th Avenue Northeast, Suite 204, Seattle, Washington, from May 9, 2011, through May 24, 2011.  During the inspection, the FDA investigators found significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) set forth in Title 21, Code of Federal Regulations, Part 1271 (21 CFR 1271), and issued under the authority of Section 361 of the Public Health Service Act (42 USC 264).

 

The deviations documented on a Form FDA 483, Inspectional Observations, were presented to and discussed with you at the conclusion of the inspection.  The items of concern include, but are not limited to, the following:

 

  1. Failure to determine as ineligible, a donor who has risk factors for, or clinical evidence of, relevant communicable disease agents or diseases [21 CFR 1271.75(d)].  For example:

 

    1. Two anonymous semen donors (donors #(b)(6) and #(b)(6)) provided a history of living their entire lives in Denmark.  The donors were not determined to be ineligible due to risk factors for variant Creutzfeldt-Jakob Disease (CJD).  Three vials of semen, collected from donor #(b)(6) on October 15, 2005, were distributed on April 12, 2010.  Two vials of semen, collected from donor #(b)(6) on October 28, 2005, were distributed on October 22, 2010.

 

    1. Anonymous semen donor # (b)(6) provided a history of previously testing positive for Hepatitis B surface antigen.  The donor was not determined ineligible and was allowed to donate on 85 occasions.  Three vials of semen, collected September 28, 2010, were distributed on April 26, 2011, and two vials of semen, collected April 20, 2010, and May 7, 2010, were distributed on April 4, 2011.
    2. Two anonymous semen donors, donor #(b)(6) and donor #(b)(6), were not determined ineligible after providing a history of spending six months in England.  The donors are ineligible to donate due to risk factors for variant Creutzfeldt-Jakob Disease. 

 

  1. Failure to determine as ineligible, a donor whose specimen tested reactive on a screening test for a communicable disease agent [21 CFR 1271.80(d)(1)].  For example, anonymous semen donor #(b)(6) tested reactive for syphilis by Fluorescent Treponemal Antibody testing on May 20, 2010.  The donor was not determined ineligible despite the reactive test result.  The results from the May 20, 2010, testing were used to release a group of semen donations collected between July 29, 2009, and November 17, 2009, from 6-month quarantine.  Donor #(b)(6) was allowed to continue donating through May 9, 2011.

 

  1. Failure to screen a donor of reproductive cells or tissue by reviewing the donor's relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases [21 CFR 1271.75(a)] and failure to perform a complete donor screening procedure within the previous six months on a living donor who was permitted to donate using an abbreviated donor screening procedure [21 CFR 1271.75(e)].  For example:

 

    1. Semen was collected from anonymous donor #(b)(6), a repeat donor, on October 17, 2009.  The last documented physical examination was performed on February 27, 2009, more than six months prior to semen collection.  Two vials of semen from this donation were distributed on April 25, 2011.

 

    1. Semen was collected from anonymous donor #(b)(6), a repeat donor, on June 18, 2009. The last documented physical examination was performed on October 2, 2008, more than six months prior to semen collection.  Three vials of semen from this donation were distributed on April 7, 2011.

 

    1. Semen was collected from anonymous donor #(b)(6), a repeat donor, on October 1, 2009. The last documented physical examination was performed on October 23, 2008, more than six months prior to semen collection.  Four vials of semen from this donation were distributed on April 7, 2011.

 

    1. Semen was collected from anonymous donor #(b)(6), a repeat donor, on February 26, 2010, and March 23, 2010. The last documented physical examination was performed on May 15, 2009, more than six months prior to semen collection.  Two vials of semen from these donations were distributed on April 4, 2011.

 

    1. Semen was collected from anonymous donor #(b)(6), a repeat donor, on May 10, 2010, and May 12, 2010. The last documented physical examination was performed on August 25, 2009, and the last medical history interview was documented on September 15, 2009, more than six months prior to semen collection. Three vials of semen from the May 10, 2010, donation were distributed on April 20, 2011, and one vial of semen from the May 12, 2010, donation was distributed on April 18, 2011.

 

    1. Semen was collected from anonymous donor #(b)(6), a repeat donor, on July 24, 2010.  The last complete medical history interview was documented on December 10, 2009, more than six months prior to semen collection.  Two vials of semen from this donation were distributed on April 26, 2011. 

 

    1. Semen was collected from anonymous donor #(b)(6), a repeat donor, on September 28, 2010. The last complete medical history interview was documented on March 18, 2010, more than six months prior to semen collection. Three vials of semen from this donation were distributed on April 26, 2011. 

 

  1. Failure to design procedures to ensure compliance with donor eligibility requirements [21 CFR 1271.47(a)].  For example, your procedure “Physical Examination” allows physical examinations of repeat anonymous semen donors at intervals up to seven months.  Under 21 CFR 1271.75(e), you may use an abbreviated screening procedure for repeat donors if you have performed a complete donor screening procedure, which includes a physical examination, within the previous six months. 

 

The deviations identified above are not intended to be an all-inclusive list of deficiencies at your facility.  It is your responsibility to ensure that your establishment is in compliance with all applicable requirements of the federal regulations.  You are responsible for reviewing your firm’s operations to assure that you are in compliance with all applicable FDA regulatory requirements. 

 

We acknowledge receipt of your letter dated June 15, 2011, providing a response to FDA's inspectional observations.  We have reviewed the corrective actions outlined in the response and have determined that the response is generally adequate.  However, we continue to have concerns about your interpretation of the donor eligibility requirements regarding risk factors for human transmissible spongiform encephalopathy (TSE), including Creutzfeldt-Jakob disease.

 

Your response discusses the distribution of semen from donor #(b)(6) and donor #(b)(6), although both donors provided a history of living their entire lives in Denmark. Your response states “As we believe the agency recognizes, the importation and shipment of donor sperm from Denmark in these two unique instances does not pose a risk to public health.” The agency’s current thinking remains the same as stated in the June 17, 2010, response to your citizen petition dated June 17, 2008, (Docket Number FDA-2008-P-0363-001/CP) that informed you that the agency does consider that sperm donations from Danish donors may pose a risk of transmission of a fatal disease for which there currently is no treatment. The regulatory requirement to screen donors for relevant communicable disease agents and diseases (RCDADs) is found in 21 CFR 1271.75(a) and TSEs, such as CJD, are listed as a RCDAD. Under 21 CFR 1271.75(d), you must determine as ineligible a donor who is identified as having a risk factor for or clinical evidence of any of the RCDADs for which screening is required under 21 CFR 1271.75(a)(1).  

 

The Guidance document for Donor Eligibility Determination specifically references 21 CFR 1271.75(a) when discussing risk factors that increase a donor’s relevant communicable disease risk and states that you should determine to be ineligible any donor who exhibits one or more of the conditions listed, in accordance with 21 CFR 1271.75(d). 21 CFR 10.115(d)(2) provides you the opportunity to choose to use an approach other than the one set forth in a guidance document. However, the alternative approach must comply with the relevant statutes and regulations. Your alternative approach of having a recipient of anonymous semen sign a waiver does not satisfy the requirements of the applicable statutes and regulations, as there is no regulation that allows for the use of a waiver in these circumstances. Secondly, this approach does not ensure the donor is free from risk factors for relevant communicable disease agents and diseases.    

 

Under 21 CFR 1271.155 you may request an exemption from a regulatory requirement; however, the regulation requires that you provide justification for use of an HCT/P from a donor, as well as information on how you have mitigated the risk consistent with the goals of protecting the public health and/or preventing the introduction, transmission, or spread of communicable diseases. There is no approved test at this time that could be used to test the donor to confirm that risk from vCJD or CJD has been mitigated.

 

You should take prompt action to correct these deviations and prevent their recurrence. Failure to do so may result in further regulatory action. 

 

We request that you notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted deviations and to prevent their recurrence.  If corrective action cannot be completed within 15 working days, state the reason for the delay and the timeframe within which the corrections will be completed.  

 

Your response should be sent to the Food and Drug Administration, Seattle District Office, 22201 23rd Drive SE, Bothell, Washington, 98021-4421, to the attention of Lisa M. Althar, Compliance Officer. Should you have any questions concerning this letter, you can contact Lisa Althar at (425) 483-4940.

 

 
Sincerely,
/S/ 
Charles M. Breen
District Director
 
 
cc:  Washington State Department of Health
       Laboratory Quality Assurance
       20435 72nd Avenue S, Suite 200
       Kent, Washington 98032