RenatiLabs Inc. – FDA Warning Letter, Aug 12, 2022

On June 1, 2023, the FDA issued a Warning Letter to RenatiLabs Inc. following an inspection from August 2-12, 2022. The FDA determined RenatiLabs' product, WJMAX™ (derived from human umbilical cord), is an unapproved drug and biological product, not solely regulated as an HCT/P under 21 CFR Part 1271. This is because it fails to meet homologous use (21 CFR 1271.10(a)(2)) and minimal manipulation (21 CFR 1271.10(a)(1)) criteria.

The product is intended for allogeneic use via intra-articular injection or topically to open wounds, purporting to be sterile and treating various conditions, which classifies it as a drug and biological product requiring a valid biologics license or an Investigational New Drug (IND) application. RenatiLabs has neither.

Significant Current Good Manufacturing Practice (CGMP) deviations were identified for over (b)(4) vials manufactured since January 2021, including: 1. Failure to reject drug products failing sterility tests (e.g., WJMAX™ lot REN20210205 contaminated with *Staphylococcus epidermidis*) [21 CFR 211.165(f)]. 2. Failure to establish and follow procedures for preventing microbiological