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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.