Vitti Labs, LLC
FDA issued a warning letter to Vitti Labs, LLC, a Liberty, MO manufacturer of human umbilical cord- and amniotic membrane-derived products (EV-PURE+, WJ-PURE+, VITTI-PURE, NS-PURE, EV-OPTI DROPS), finding that these HCT/Ps are unapproved biological drug products marketed without a valid biologics license application (BLA) or investigational new drug (IND) application. The products failed to meet the homologous-use and minimal-manipulation criteria under 21 CFR 1271.10(a), and the inspection documented significant CGMP deviations including unvalidated aseptic processes, inadequate environmental monitoring, and unsupported two-year expiration dating. FDA warned that failure to adequately respond may result in seizure and/or injunction.
Flagged claims (4)
your products 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
using these products to treat orthopedic diseases or conditions, for example, is not homologous use as defined in 21 CFR 1271.3(c)
your firm has assigned a two-year expiration date to your products without adequate data regarding the stability characteristics of the products
Required actions (3)
We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
Failure to adequately address these matters may lead to regulatory action without further notice. Such actions include seizure and/or injunction.
Your response also does not adequately address your failure to have an IND in effect to study your products addressed in this letter or your lack of an approved BLA to lawfully market your products.
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