FDA WARNING_LETTER - Regenerative Processing Plant, LLC - June 30, 2023

The FDA issued a Warning Letter to Regenerative Processing Plant, LLC (RPP) following an inspection from June 20-30, 2023. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211) in the manufacturing of Regener-Eyes® PRO and Regener-Eyes® LITE Ophthalmic Solutions. These products, distributed nationwide, are deemed adulterated under section 501(a)(2)(B) of the FD&C Act.

Furthermore, Regener-Eyes® PRO and Regener-Eyes® LITE are classified as unapproved new drugs under section 505(a) and misbranded under sections 502(a) and 502(ee) of the FD&C Act. The products do not conform to OTC Monograph M018 for ophthalmic demulcents, specifically regarding the unpermitted active ingredient "Tonicity Solution Sodium Chloride" and missing required labeling warnings. Misleading claims on labeling and websites, such as "FDA registered OTC drug" and "in full compliance with the FDA," contribute to misbranding.

CGMP violations include: 1. Failure to validate aseptic processes, evidenced by contaminated media fill batches and inadequate incubation/examination of filled units. 2. Inadequate environmental monitoring, lacking defined alert/action levels and growth promotion testing for media