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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-20/
- Published: 2020-04-14T12:00:00.000Z
- Updated: 2026-09-14T16:11:18.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146568

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.  
  
**American Fertility Medical Center**, Irvine, CA (4/2): FDA inspected the firm 1/14-22 and documented significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. For example, FDA said the medical center failed to test a specimen from an anonymous or directed reproductive donor of cells or tissue for evidence of infection due to relevant communicable disease agents. It also failed to determine as ineligible a donor whose specimen tests reactive on a screening test for a communicable disease agent. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/american-fertility-medical-center-genetic-infertility-andrology-lab-605068-04022020?ref=fdaweb.com).

**HomeChoice Partners**, Bannockburn, IL (4/9): FDA inspected the firm 8/13-17/2018 and cited serious deficiencies in its practices for producing sterile drug products. FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing the drug products to be adulterated. The company also failed to sanitize tubing between production of different sterile drug products. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/homechoice-partners-inc-606962-04092020?ref=fdaweb.com).

**Gaia Arise Farms Apothecary**, Waynesville, NC (4/13): FDA and the Federal Trade Commission reviewed the firm’s Web site and Facebook page where True Viral Defense or Viral Defense Tincture was being marketed to mitigate, prevent, treat, diagnose, or cure Covid-19\. The letter tells the company to “take immediate action to cease the sale of such unapproved and unauthorized products. for the mitigation, prevention, treatment, diagnosis, or cure of Covid-19.” The agency advised the company to review its Web sites, product labels, and other labeling and promotional materials to ensure that it is not misleadingly representing products as safe and effective for a Covid-19-related uses. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gaia-arise-farms-apothecary-606668-04132020?ref=fdaweb.com).