Inspections, Compliance, Enforcement, and Criminal Investigations

The Centre for Reproductive Medicine 8/15/13

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128

 

August 15, 2013
 
2013-DAL-WL-046
 
WARNING LETTER
UPS Overnight
 
Mikal J. Dorsett, MD
Owner
The Centre for Reproductive Medicine
3405 22nd St., Suite 300
Lubbock, Texas 79410-1348
 
Dear Dr. Dorsett:
 
The Food and Drug Administration (FDA) conducted an inspection of your firm, located at 3405 22nd St., Suite 300, Lubbock, Texas, from June 14 through June 21, 2013. During this inspection, the FDA investigator documented 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 the Form FDA-483, lnspectional 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 test a specimen from an anonymous or directed reproductive donor of cells and tissue, whether viable or non-viable, for evidence of infection due to relevant communicable disease agents [21 CFR 1271.85(a)] and failure to test for relevant communicable disease agents of the genitourinary tract, including Chlamydia trachomatis and Neisseria gonorrhea [21 CFR 1271.85(c)). Specifically,
 
The donor specimens collected from directed oocyte donor MRN # (b)(6) on December 5, 2012 were not tested for human immunodeficiency virus, type 1 (HIV-1) and type 2(HIV-2), Hepatitis B Surface Ag, Hepatitis B Core, Hepatitis C virus (HCV), Treponema palladium, Chlamydia trachomatis and Neisseria gonorrhea . The physical exam form dated November 16, 2012 indicates donor MRN # (b)(6)  was an "approved egg donor candidate". Oocytes were recovered on December 5, 2012.
 
2.    Failure to collect a donor specimen for testing for relevant communicable diseases within 30 days prior to oocyte recovery, or up to 7 days after recovery [21 CFR 1271.80(b)]. Specifically,
 
The communicable disease testing samples for anonymous oocyte donor #(b)(6) were collected on August 13, 2012. Oocytes were recovered on October 11, 2012 outside of the 30 day testing requirement.
 
3.    Failure to screen an anonymous or directed reproductive donor of 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)]. Records selected for review of directed and anonymous oocyte donors did not include complete documentation of relevant medical records including physical exams and history noted in 21 CFR 1271.3(s) as part of the donor's relevant medical records. Specifically, there is no record of
 
a.    A donor physical exam [Oocyte Donor Physical Examination form (DE-01.F3)] for anonymous oocyte donor #(b)(6). Oocytes were recovered on July 18, 2012.
b.    A donor physical exam [Oocyte Donor Physical Examination form (DE- 01.F3)] for anonymous oocyte donor #(b)(6). Oocytes were recovered on December 13,2012.
c.    A medical history [Donor Application-Medical and Genetic History form (DE-01.F1)] for directed oocyte donor MRN #(b)(6). Oocytes were recovered on December 5, 2012.
d.    A medical history [Donor Application-Medica/ and Genetic History form (DE-01.F1)] for directed oocyte donor MRN #(b)(6). Oocytes were recovered on May 8, 2013.
 
4.    Failure to make donor-eligibility determinations based upon the results of donor screening and donor testing. A responsible person must determine and document the eligibility of a cell or tissue donor [21 CFR 1271.50 (a)]. Specifically, there is no record of
 
a.    Donor eligibility [Oocytes Donor Eligibility Summary of Records form (DE- 01.F2)] for directed oocyte donor MRN #(b)(6). Oocytes were recovered on December 5, 2012.
b.    Donor eligibility [Oocytes Donor Eligibility Summary of Records form (DE- 01.F2)] for directed oocyte donor MRN #(b)(6). Oocytes were recovered on May 8, 2013.
c.    Donor eligibility [Oocytes Donor Eligibility Summary of Records form (DE- 01.F2)] for anonymous oocyte donor #(b)(6). Oocytes were recovered on October 11, 2012.
d.    Donor eligibility [Oocytes Donor Eligibility Summary of Records form (DE- 01.F2)] for anonymous oocyte donor #(b)(6). Oocytes were recovered on April 15, 2011, June 24, 2012 and May 17, 2013.
e.    Donor eligibility [Oocytes Donor Eligibility Summary of Records form (DE- 01.F2)] for anonymous oocyte donor #(b)(6). Oocytes were recovered on September 14, 2011, August 22, 2012, November 8, 2012 and April 24, 2013.
 
5.    You failed to maintain documentation of the donor-eligibility determination, including the name of the responsible person who made the determination and the date of the determination [21 CFR 1271.55(d)(iii)]. Specifically,
 
a. There is no documentation of the identity of who performed the donor eligibility determination for:
 
1.    The medical history interview was conducted and the Donor Application-Medical and Genetic History form (DE-01.F1) was completed on June 20, 2007 for anonymous oocyte donor #(b)(6). Oocytes were recovered on July 28, 2011 and September 17, 2012.
2.    The medical history interview was conducted and the Donor Application-Medical and Genetic History form (DE-01.F1) was completed on May 26, 2009 for anonymous oocyte donor #(b)(6). Oocytes were recovered on March 28, 2011.
3.    The medical history interview was conducted and the Donor Application-Medical and Genetic History form (DE-01.F1) was completed on August 4, 2010 for anonymous oocyte donor #(b)(6). Oocytes were recovered on September 14, 2011, August 22, 2012, November 8, 2012 and April 24, 2013.
4.    The medical history interview was conducted and the Donor Application-Medical and Genetic History form (DE-01.F1) was completed on July 24, 2009 for anonymous oocyte donor #(b)(6). Oocytes were recovered on July 18, 2012.
5.    The medical history interview was conducted and the Donor Application-Medical and Genetic History form (DE-01.F1) was completed on August 21, 2012 for anonymous oocyte donor #(b)(6). Oocytes were recovered on December 13, 2012.
 
b.    The physical examination was conducted and the Oocyte Donor Physical Examination form (DE-01.F3) was completed on July 19, 2012 for anonymous oocyte donor #(b)(6). The second page of the physical exam form is incomplete. Oocytes were recovered on October 11, 2012.
 
We acknowledge your written responses dated July 1, 2013 and July 3, 2013. We have reviewed the corrective actions outlined in the response and we have determined that the response is inadequate to address our concerns. The response outlines plans to revise documents and implement a (b)(6) tier review. However, your response failed to provide documents to support corrective actions for donor eligibility, record keeping and communicable disease testing deficiencies.
 
It is your responsibility to ensure your establishment is in compliance with all applicable requirements of the federal regulations. Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. 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.
 
Please send your reply to the Food and Drug Administration, Attention: Elvia J. Cervantes, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in this letter, please contract Ms. Cervantes at 214-253-5236.
 
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director

 

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