FDA warning letter Archives

Celularity & 2 other perinatal biologics firms get FDA warnings

December 16, 2025 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

Three recent FDA warning letters, including one issued to publicly-traded Celularity, paint a helpful picture of where FDA oversight stands. They illustrate how the FDA’s classification of placental/amniotic products greatly depends on how a firm positions a product clinically. The marketing is key. Comparing these warnings three letters offers a useful window into current and […]

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Weekly reads: FDA warnings on immunotherapy toothpaste & exosomes, upbeat SCID work, animal model alternatives

October 26, 2025 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

Did you know there’s immunotherapy toothpaste? It’s intended to provide immunotherapy of a kind while you brush. Some of this is meant to help allergies so the products can also be called allergenic toothpastes. Let’s start this week’s recommended reads with a warning from the FDA here. Immunotherapy toothpaste Allerdent I became aware of this

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2 FDA warnings to perinatal firms including Platinum Biologics paradoxically provide hope

September 9, 2025 / Professor Paul Knoepfler, Ph.D. / 5 Comments

Perinatal biologics supplier Platinum Biologics recently received an FDA warning letter. A second perinatal biologics firm, Innate Healthcare Institute, was also recently warned. I’m primarily going to focus on the warning to Platinum Biologics, but both letters have a paradoxical element to them. Why? These warnings provide some hope of normalcy in FDA biologics oversight

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Reading the stem cell tea leaves as Trump FDA warns 2 perinatal biologics firms including Supreme Rejuvenation

May 29, 2025 / Professor Paul Knoepfler, Ph.D. / 2 Comments

The FDA’s biologics or CBER branch just warned two perinatal biologics firms. In a way, these letters surprised me more than any in recent years. Up to this point, I had not seen any posted warning letters from the Trump 2.0 FDA to stem cell clinic or biologics supplier-type firms. Part of me thought that

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FDA letters to Chara Biologics & Evolutionary Biologics continue its unprecedented slew of warnings

February 6, 2025 / Professor Paul Knoepfler, Ph.D. / 11 Comments

What is Chara Biologics? Why did the FDA just warn them and another firm? FDA’s CBER keeps up fast pace of warnings Before we get into that, the FDA biologics branch, CBER, has more generally kept up an unprecedented pace of warning letters over the past 13 months. I wrote late last year how 2024

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NAE member Mary Pat Moyer on FDA Warning Letter to her firm INCELL Corporation

February 4, 2025 / Professor Paul Knoepfler, Ph.D. / 4 Comments

A Texas firm called INCELL Corporation has received an FDA warning letter about an amniotic product it manufactures. The letter was addressed to the firm’s founder and leader Dr. Mary Pat Moyer. The letter is somewhat unusual as Dr. Moyer is the Chief Science Officer of INCELL, and is an academic scientist with over 250

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FDA warns Frontier Biologics as part of its more active trend

December 3, 2024 / Professor Paul Knoepfler, Ph.D. / 2 Comments

The FDA recently warned Frontier Biologics, LLC, a Texas perinatal tissue manufacturer firm. Tallying the many FDA biologics warnings in 2024 It can sometimes feel like there are an uncountable number of unproven stem cell clinics However, the good news is that the FDA has been doing much more on this front in 2024. With

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FDA’s CBER fires off 3 more warning letters on cellular biologics for a total of 12 in 2024

October 29, 2024 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

Something seems to have dramatically changed with the FDA at its Center for Biologics Evaluation and Research or CBER. Did they start handing out free Red Bull by the case? So many recent FDA warnings on cell and tissue biologics CBER is the part of the FDA that regulates regenerative medicine products like stem cells,

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Big spike in FDA warning letters to unproven biologics firms

October 1, 2024 / Professor Paul Knoepfler, Ph.D. / 2 Comments

Dr. Peter Marks, Director of CBER, FDA warning

This year already appears to be a record one for cell and tissue therapy-related warning letters the FDA. Directly or indirectly, these come from the FDA’s Center for Biologics Evaluation and Research or CBER. Something unusual seems to be happening. FDA’s CBER has been exceptionally active in 2024 including on cell & tissue products I’ve

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Regener-Eyes maker gets FDA warning on amniotic eye drops

September 12, 2024 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

The FDA alerted the public about issues related to amniotic eye drops last year and now the agency just warned the manufacturer of one such product called Regener-Eyes. The manufacturer is Regenerative Processing Plant, LLC. The warning letter was addressed to its owner, Carl R. Harrell, MD. What’s the deal with this warning? Let’s start

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