FDA WARNING_LETTER - Vitti Labs, LLC - December 20, 2021

The FDA issued a Warning Letter to Vitti Labs, LLC, following an inspection from December 6-20, 2021. The inspection documented the manufacture and distribution of human umbilical cord-derived products (EV-PURE+, WJ-PURE+, VITTI-PURE) and human amniotic membrane-derived products (NS-PURE, EV-OPTI DROPS) for allogeneic use. These products, intended for injection, ophthalmic, and topical administration, are deemed unapproved drugs and biological products under the FD&C Act and PHS Act, as they do not meet the criteria for regulation solely as HCT/Ps (21 CFR 1271.10(a)). Specifically, they are not for homologous use and are more than minimally manipulated.

Vitti Labs lacks an approved Biologics License Application (BLA) and an Investigational New Drug (IND) application for these products, which are required for lawful marketing and clinical use.

The letter also cited significant Current Good Manufacturing Practice (CGMP) deviations, including: 1. Failure to validate aseptic and sterilization processes, including media fills and equipment sterilization (e.g., (b)(4) sterilizer). 2. Inadequate environmental monitoring procedures, with excessively high action limits for microbiological and non-viable particulate contamination, and insufficient monitoring frequency and locations. 3. Uncleanable ceilings in the aseptic processing area due to suspended unused equipment