The FDA continued to issue warning letters to firms that distribute unapproved products for the prevention and treatment of COVID-19 infections. No warning letters were issued to drug manufacturers or compounding pharmacies, but the FDA did issue the following:
- Two untitled letters issued by CBER to firms distributing cell-based products.
- Two warning letters issued to manufacturers of breast implants for which the FDA issued the following press release.
Also issued but not covered here was a group of warning letters from the Center for Tobacco Products.
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Drug Warning and Untitled Letters
Sparrow Health & Performance, LLC
Sparrow Health & Performance, LLC (Hoover, AL) received an untitled letter from CBER on May 11, 2020, based on an FDA review of the firm’s website and Facebook page. The firm advertises cell products derived from adipose tissue to treat a range of diseases, including a current ad for adipose tissue-derived cell products to prevent or treat COVID-19 infections. The firm does not appear to qualify for an exemption from 21CFR 1271 applies. These products are HCT/P products.
The FDA also notes that the company’s websites identify exosomes as one of their “services.” Previous untitled letters to Regenerative Solution of New Jersey and Infuze MD and Kimera, who are associated with exosome products.
Valeo MD PA Lab LLC dba ValeoMD
Valeo MD PA Lab LLC dba ValeoMD received an untitled letter on April 28, 2020, based on a review of products offered on their website. The products include stem cell therapies derived from adipose tissue. The products are advertised to treat a collection of medical conditions including asthma, COPD, concussions, PTSD, and traumatic brain injury. These products should be governed as HCT/P products and the associated regulations.
Device Warning and Untitled Letters
Allegran (Irvine, CA)
Allergan received a warning letter on May 14, 2020, based on their failure to comply with post-approval study requirements that were part of the conditions of device approval. The FDA cites failure to comply with 21CFR 814.82(a). The FDA also notes, at the end of a very lengthy warning letter, that failure to complete these studies may result in withdrawal of approval for the PMA.
Ideal Implant Incorporated (Dallas, TX)
Ideal Implant Incorporated received a warning letter on May 14, 2020, based on the outcome of an inspection ending February 3, 2020. Deficiencies include but are not limited to:
- The firm failed to document complaint investigations and MDR evaluations by a formally designated unit.
- The firm failed to document corrective actions taken to remediate rejection of sterilization loads at their contract manufacturer.
- The firm did not establish a procedure for finished device acceptance.
- FDA determined that the devices are misbranded because the firm failed or refused to “furnish material or information respecting the device that is required under section 519 of the Act.” The firm failed to report certain adverse events as MDRs. The FDA notes that the firm did recall the products in question.
- The firm’s MDR procedures are not adequate.
BIMO, GCP and GLP Warning and Untitled Letters
No letters were issued this week.
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