Vitti Labs Warning Letter
What happened
On July 28, 2022, the Food and Drug Administration issued a Warning Letter to Vitti Labs.
Why is this relevant to Regener-Eyes?
Vitti Labs makes an eye drop quite similar to Regener-Eyes. It is called EV-OPTI and is described as “Lubricating Growth Factor Drops” which consist of a “placental derived matrix providing growth factors, cytokines….” Sound familiar?
Hmmmm.
I just tried to link to the Regenereyes page that describes Regenereyes as derived from placenta, and whaddayaknow, it’s GONE. Gosh, do you think that might be our fault?
Thankfully, waybackmachine keeps a record:
Now what does the warning letter say?
Dear Mr. Vitti, Dr. Bartalos, and Ms. McKinney:
During an inspection of your firm… the United States Food and Drug Administration (FDA) documented your manufacture of products derived from human umbilical cord, EV-PURE+, WJ-PURE+, and VITTI-PURE, or human amniotic membrane, NS-PURE, and EV-OPTI DROPS (collectively, “your products”) for allogeneic use1. You have distributed your products to third-party distributors, some under private label, and directly to health care professionals and medical facilities for use in patients2. Your products are intended for injection, ophthalmic administration, and/or topical application and purport to be sterile.
…. Your products are intended for clinical use in humans to treat a variety of diseases or conditions. Therefore, your products are drugs…. Your products are also human cells, tissues, or cellular or tissue-based products….Such products are regulated as drugs, devices, and/or biological products… Vitti Labs does not qualify for any exception in 21 CFR 1271.15, and your products fail to meet all the criteria in 21 CFR 1271.10(a)….
….Please be advised that to lawfully market a drug that is a biological product, a valid biologics license must be in effect [42 U.S.C. 262(a)]. Such licenses are issued only after showing that the product is safe, pure, and potent. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect as specified by FDA regulations [21 U.S.C. 355(i); 42 U.S.C. 262(a)(3); 21 CFR Part 312]. None of your products are the subject of an approved biologics license application (BLA), nor is there an IND in effect for your products. Based on this information, your actions have violated the FD&C Act and the PHS Act….
….Additionally, during the inspection, FDA investigators documented evidence of significant deviations from current good manufacturing practice (CGMP) requirements, including deviations from section 501(a)(2)(B) of the FD&C Act and 21 CFR Parts 210 and 211….
….While in the development stage, such a product may be distributed for clinical use in humans only if the sponsor has an IND in effect for that product, as specified by FDA regulations, that covers such clinical use [21 U.S.C. 355(i); 42 U.S.C. 262(a)(3); 21 CFR Part 312]…..