Carl R. Harrell, MD
Owner, Chairman, CEO, and Medical Director
Regenerative Processing Plant, LLC
34176 US Highway 19 N
Palm Harbor , FL 34684-2144
United States
dr.harrell@regenerativeplant.orgFEI 3011320041Issued Aug 16, 2024Center for Biologics Evaluation and Research
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3011320041.
Violations11
Issue DateAug 16, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
Regenerative Processing Plant, LLC
Location
Carl R. Harrell, MD
Owner, Chairman, CEO, and Medical Director
Regenerative Processing Plant, LLC
34176 US Highway 19 N
Palm Harbor , FL 34684-2144
United States
dr.harrell@regenerativeplant.org
FEI Number
3011320041
Country
United States
Issue Date
August 16, 2024
Issuing Office
Center for Biologics Evaluation and Research
Product Type
Drugs
Status
Open
Summary
Regenerative Processing Plant, LLC was cited for manufacturing two ophthalmic drug products (Regener-Eyes® PRO and Regener-Eyes® LITE Ophthalmic Solutions) that violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering the products adulterated. The company manufactured these sterile, preservative-free products in multiple-dose containers and distributed them directly to optometrists, eye clinics, and patients nationwide without adequate manufacturing controls or methods. Additionally, the products were deemed unapproved new drugs introduced into interstate commerce in violation of federal law.
Regenerative Processing Plant, LLC FDA Warning Letter, August 16, 2024
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