Regener-Eyes addresses violations cited in FDA warning letter
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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 both products as “unapproved new drugs” being marketed in violation of interstate commerce law.
In order for ophthalmic products to be legally marketed without an approved application, they must conform to OTC monograph conditions, which Regener-Eyes drops failed to do, based on inclusion of certain active ingredients in the formulation, the letter stated.
In addition to product labeling violations, the letter states that the plant “failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile and that include validation of all aseptic and sterilization processes.”
Specific violations, based on an FDA inspection conducted between June 20, 2023, and June 30, 2023, included failure to adequately monitor environmental conditions, establish a testing program to assess stability of drug products and verify the identity of each component of a product, among others.
The letter also alleges that “during the inspection, your chief strategist claimed that your firm discontinued manufacturing Regener-Eyes Ophthalmic Solution containing amniotic fluid in approximately June 2021 and represented that any remaining amniotic fluid at your facility is used for research purposes.”
However, the FDA found that the company continued to receive shipments of amniotic fluid and that the unit donor IDs identically corresponded to lot codes within inventory and batch records for Regener-Eyes eye drops, suggesting continued use, despite the FDA informing the company that use of placental-derived biomaterial requires a valid biologics license.
According to the letter, the FDA has reviewed correspondence from Regener-Eyes, which detailed several corrective actions, some of which were deemed “not adequate” by the FDA. The company, which was given 15 working days from receipt of the letter to outline specific steps they have taken or will take to address violations and prevent recurrence, told Healio they have addressed these concerns, notably implementing improvements to manufacturing procedures and using new preservative-free bottles.
“Regener-Eyes has been proactive in already addressing and eliminating the misbranding concerns brought up by the FDA,” the company said. “We have revised our marketing practices and claims to align with OTC monograph drug standards.”
They continued, “Our commitment to adhering to cGMP standards is unwavering, and we prioritize both patient safety and regulatory compliance. Ensuring that our products benefit patients while maintaining transparency with health care professionals is central to our mission.”
Reference:
- Products. https://regenereyes.com/collections/all. Published Aug. 3, 2024. Accessed Sept. 19, 2024.
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