After receiving a warning letter from the FDA on Aug. 16 citing “significant violations” related to two Regener-Eyes ophthalmic products, the company has implemented several improvements to address the concerns.
According to the FDA, Regener-Eyes and its manufacturer, Regenerative Processing Plant, have distributed multi-dose Regener-Eyes Professional Ophthalmic Solution and Regener-Eyes Lite Ophthalmic Solution directly to optometrists, eye clinics and consumers in the U.S. as sterile, preservative-free products intended for dry eye relief. Because of this claim, the FDA described