FDA Warning Letters Week of 4/13/2020: HCT/P & Compounding Pharmacy

This week saw the continued posting of warning letters issued to those selling unapproved new drugs to prevent, diagnose or treat COVID-19 infections.  I’m sure these represent only the tip of the iceberg and will continue for a couple of years.

Among the areas we cover, FDA posted one warning letter issued to a fertility clinic governed by the HCT/P regulations and one to a compounding pharmacy.

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HCT/P BIOLOGICS | American Fertility Medical Center Genetic Infertility & Andrology Lab (Irvine, CA)

American Fertility Medical Center, Genetic Infertility & Andrology Lab received a warning letter on April 2, 2020, based on the outcome of an inspection ending January 22, 2020.  The site is governed by the HCT/P regulations and guidance.

The speed with which this warning letter was issued speaks to the potential public health risk posed by the firm’s practices.  The firm has not yet responded to the FDA form 483.  This follows on the heels of recent inspections where FDA also noted they “… found additional significant violations upon further review of the documents collected during the inspection.”  Thus, more deficiencies are identified in the warning letter than were identified on the form 483 issued at the close of the inspection.

FDA notes that the firm must request an exemption from 21CFR1271.155 if removing any sperm or oocytes from quarantine status, or moving them to another facility.  Deficiencies focus on lack of donor screening and/or lack of documentation to support donor screening.

Deficiencies include but aren’t limited to:

  • Failure to test for virtual infections.  Missing in some cases were testing for HIV ½, hepatitis B, hepatitis C, syphilis, gonorrhea, and chlamydia.

  • Donors whose specimens tested reactive on a screening test were not deemed to be ineligible.

  • Failure to review the donor’s medical history for risk factors and clinical evidence of communicable disease.

  • Donor records with missing documentation of medical history review and missing documentation of a physical examination.


COMPOUNDING PHARMACY | HomeChoice Partners, Inc

HomeChoice Partners, Inc (Bannockburn, IL) received a warning letter on April 9, 2020 based on the outcome of an inspection ending August 17, 2020.

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