Regenerative Processing Plant, LLC
FDA issued a Warning Letter to Regenerative Processing Plant, LLC (owner Dr. Carl R. Harrell) in Palm Harbor, FL, citing multiple serious violations related to their Regener-Eyes® PRO and Regener-Eyes® LITE ophthalmic solutions. The products were found to be unapproved new drugs, misbranded, and adulterated due to significant CGMP failures including inadequate aseptic process validation, insufficient environmental monitoring, and unsupported stability claims. FDA also raised serious concerns that products marketed after June 2021 may still contain amniotic fluid — a biologic requiring a valid BLA — despite the company's claims of discontinuation. Failure to adequately address these violations may result in seizure and/or injunction.
Flagged claims (11)
FDA approvals are typically associated with prescription drugs, whereas [OTC] drugs undergo FDA registration and regulation.
in full compliance with the FDA.
Regener-Eyes® Tonicity Solution™ employs patented technology to combat dry eye-triggering hyperosmolarity.
A New Therapeutic Agent to Relieve Dryness of the Eye for Tear Hyperosmolarity-Induced Pathological Changes in the Eyes of Patients Suffering From Dry Eye Discomfort.
stored at room temperature and used within 90 days
Dry Eye Relief Made Simple
Tear hyper-osmolarity (THO) is a primary culprit in dry eye problems.
Regener-Eyes® is a ... FDA registered OTC drug
Relieve Dryness of the Eye.
Regener-Eyes® Tonicity SolutionTM . . . combats dry eye-triggering hyperosmolarity
Regener-Eyes® Tonicity SolutionTM is a "Breakthrough Solution…[I]ts hypotonic solution, enriched with osmoprotectants, target tear hyperosmolarity directly, enhancing tear stability crucial for symptom relief. This innovative formula represents a significant advancement in the treatment of dry eye."
Required actions (3)
We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
Please inform FDA in response to this letter whether you are willing to take additional voluntary actions with respect to this distributed product.
Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.
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