The FDA has issued a warning letter to Regenerative Processing Plant after conducting an inspection of the facility. The plant manufactures two ophthalmic drug products, Regener-Eyes Professional Ophthalmic Solution and Regener-Eyes LITE Ophthalmic Solution.
Regenerative distributes ophthalmic products directly to optometrists, eye clinic facilities and patients throughout the U.S., according to the Aug. 16 letter.
The letter cites the facility for incorrectly packaging and misbranding eye products. Specifically, the FDA contends the eyedrops are made with ingredients that are not approved by the FDA to treat dry eyes, which the product is marketed to do.
"You represent that your products are 'in full compliance with the FDA.' As stated above, your Regener-Eyes products are not in full compliance with statutory requirements enforced by the FDA because these products are unapproved new drugs that are not exempt from approval, and misbranded drugs," the letter reads.
In addition, the FDA found several manufacturing violations and failures. Among them, the FDA found the Regenerative plant failed
- to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile,
- to have an adequate system for monitoring environmental conditions in an aseptic processing area necessary to prevent contamination or mixups,
- to establish and follow an adequate written testing program,
- to conduct at least one test to verify the identity of each component of a drug product,
- to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced,
- to have an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions,
- to maintain production, control, or distribution records, and
- to retain an appropriately identified reserve sample that is representative of each lot or batch of drug product.
The FDA requested that Regenerative respond in writing within 15 working days to outline the specific steps it has taken, or plans to take, to address any violations and prevent their recurrence.