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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Jeffrey Steinberg MD Inc., d/b/a The Fertility Institutes

   

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

Public Health Service
Food and Drug Administration
  Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612·2506
Telephone: 949-608·2900
FAX: 949-608-4415


WARNING LETTER


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


November 18, 2008

W/L 06-09

Jeffrey Steinberg, M.D.
Medical Director/President
Jeffrey Steinberg MD Inc., d/b/a The Fertility Institutes
16030 Ventura Blvd., Ste 404
Encino, CA 91436-2731


Dear Dr. Steinberg:


The United States Food and Drug Administration (FDA) conducted an inspection of your firm, located at 16030 Ventura Blvd., Ste. 404, Encino, California, from July 23, 2008 through August 8, 2008. During the inspection, the FDA investigator documented significant deviations from the regulations governing 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), issued under the authority of Section 361 of the Public Health Service Act (42 USC 264).


At the close of the inspection, FDA issued to you a Form 483, Inspectional Observations, that describes a number of deviations. The items of concern include, but are not limited to, the following:


1. Failure to test a specimen from a donor of reproductive cells or tissue to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents of the genitourinary tract, including Chlamydia trachomatis and Neisseria gonorrhea [21 CFR 1271.85(c)]. Specifically, semen was recovered and used for fertilization of oocytes that were ultimately transferred to recipients despite the absence of testing for these diseases. Your establishment failed to test specimens from semen donors (b) (6), and (b) (6) for Chlamydia trachomatis and/or Neisseria gonorrhea in the following instances here the reproductive cells or tissue were not recovered by a method that ensures freedom from contamination of the cells or tissue by infectious disease organisms that may be present in the genitourinary tract:


a. On (b) (6), semen was collected from directed donor (b) (6) who was also the intended, parent, and was frozen for future use. On (b) (6), the frozen semen was used to fertilize oocytes from an anonymous oocyte donor. On (b) (6) resulting embryos were transferred to surrogate (b) (6)


b. On (b) (6), semen was collected from directed donor (b) (6) who was also the intended parent, and was frozen for future use. On (b) (6), the frozen semen was used to fertilize oocytes from an anonymous oocyte donor. On (b) (6) resulting embryos were transferred to surrogate (b) (6)


c. On (b) (6), semen was collected from directed donor (b) (6) who was also the intended parent, and was frozen for future use. On (b) (6) the frozen semen was used to fertilize oocytes from an anonymous oocyte donor. On (b) (6) resulting embryos were transferred to surrogate (b) (6)


d. On (b) (6), semen was collected from directed donor (b) (6) who was also the intended parent, and was frozen for future use. On (b) (6) the frozen semen was used to fertilize oocytes from an anonymous
oocyte donor. On (b) (6) resulting embryos were transferred to surrogate (b) (6)


e. On (b) (6), semen was collected from directed donor (b) (6) who was also the intended parent, and was used to fertilize oocytes from an anonymous oocyte donor. On (b) (6) resulting embryos were transferred to surrogate (b) (6)


2. Failure to test a specimen from the donor of viable, leukocyte-rich cells or tissue to adequately and appropriately reduce the risk of transmission of relevant communicable diseases [21 CFR 1271.85(b)(2)]. Specifically, your establishment failed to test for cytomegalovirus (CMV) for semen donors 

(b) (6) and (b) (6) in the following instances:


a. On (b) (6), semen was collected from directed donor (b) (6), who was also the intended parent, and was frozen for future use. On (b) (6), the frozen semen was used to fertilize oocytes from an anonymous oocyte donor. On (b) (6) resulting embryos were transferred to surrogate (b) (6)


b. On (b) (6) semen was collected from directed donor (b) (6) who was also the intended parent, and was frozen for future use. On (b) (6), the frozen semen was used to fertilize oocytes from an anonymous oocyte donor. On (b) (6) resulting embryos were transferred to surrogate (b) (6)


c. On (b) (6), semen was collected from directed donor (b) (6) who was also the intended parent, and was frozen for future use. On (b) (6), the frozen semen was used to fertilize oocytes from an anonymous oocyte donor. On (b) (6) resulting embryos were transferred to surrogate (b) (6)


d. On (b) (6), semen was collected from directed donor (b) (6) who was also the intended parent, and was frozen for future use. On (b) (6) the frozen semen was used to fertilize oocytes from an anonymous
oocyte donor. On (b) (6) resulting embryos were transferred to surrogate (b) (6)


e. On (b) (6) semen was collected from directed donor (b) (6) who was also the intended parent, and was used to fertilize oocytes from an anonymous oocyte donor. On (b) (6) resulting embryos were transferred to surrogate (b) (6)


3. Failure to collect a donor specimen for testing for relevant communicable diseases within 30 days prior to oocyte recovery or up to seven days after oocyte recovery or up to seven days before or after recovery of semen [21 CFR l271.80(b)]. Specifically, specimens from the following donors were not collected within the required time frames:


a. The specimen from anonymous oocyte donor (b) (6) was collected for testing on (b) (6); however oocyte recovery was performed on (b) (6).


b. The specimen from directed oocyte donor (b) (6) was collected for testing on (b) (6); however oocyte recovery was performed on (b) (6).


c. The specimen from directed semen donor (b) (6) was collected for testing on (b) (6); however semen collection occurred on (b) (6).


4. Failure to screen an anonymous or directed 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)). Specifically, records for the following donors did not include documentation of a donor medical history interview, as defined in 21 CFR 1271.3(n), and/or physical examination of a living donor, both of which are required as relevant medical records [21 CFR 1271.3(s)].


a. Semen was collected from directed donor (b) (6) and was used to fertilize oocytes from an anonymous oocyte donor. The resulting embryos were transferred to a surrogate. Semen donor (b) (6) did not have documentation of a physical examination or a donor medical history interview prior to semen collection on (b) (6).


b. Oocytes were recovered from anonymous donor (b) (6) and were fertilized with semen from directed donors (b) (6). The resulting embryos were transferred to a surrogate. Oocyte donor (b) (6) did not have documentation of a donor medical history interview prior to oocyte recovery on (b) (6).


c. Oocytes were recovered from directed donor (b) (6) and were fertilized with semen from the donor's partner, directed donor (b) (6). The resulting embryos were transferred to a surrogate. Oocyte donor (b) (6) and semen donor (b) (6) did not have documentation of a donor medical history interview prior to oocyte recovery on (b) (6) and semen collection on (b) (6).


d. Semen was collected from directed donor (b) (6) and was used to fertilize oocytes from an anonymous oocyte donor. The resulting embryos were transferred to a surrogate. Semen donor (b) (6) did not have documentation of a physical examination prior to semen collection on (b) (6).


e. Semen was collected from directed donor (b) (6) and was used to fertilize oocytes from an anonymous oocyte donor. The resulting embryos were transferred to a surrogate. Semen donor (b) (6) did not have documentation of a physical examination prior to semen collection on (b) (6).


f. Semen was collected from directed donor (b) (6) and was used to fertilize oocytes from an anonymous oocyte donor. The resulting embryos were transferred to a surrogate. Semen donor (b) (6) did not have documentation of a physical examination or donor medical history interview prior to semen collection on (b) (6).


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 requirements of the law and applicable federal regulations. You are responsible for investigating, determining causes of, and correcting the violations identified by FDA, and for reviewing your firm's operations as a whole to ensure that you and your firm are in compliance, with the FDA regulatory requirements applicable to human reproductive HCT/Ps. You should take prompt action to correct these deviations and prevent their recurrence. Failure to do so may result in FDA initiating regulatory action without further notice. For example, FDA may take possession of and/or destroy violative HCT/Ps, or may issue an order to retain, recall, destroy, or cease manufacture of HCT/Ps.


We request that you notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent their recurrence. If you cannot complete all the corrections before you respond, please state the reason for your delay and the time frame within which the corrections will be completed. 

 

If you have any questions regarding this letter, please contact Ms. Mariza Jafary, Compliance Officer at 949-608-2977.

Your written reply should be sent to:


J. Lawrence Stevens
Acting Director, Compliance Branch
US Food & Drug Administration
19701 Fairchild
Irvine, CA 92612-2446

 

Sincerely,

 

/S/

 

Alonza E. Cruse

District Director

Los Angeles


Cc: Jeff Farrar, DVM, PhD, MPH
Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413