CARsgen Therapeutics Corporation – FDA Warning Letter, Dec 6, 2023

The FDA inspected the facility at 4022 Stirrup Creek Drive, Durham, NC, from November 28 to December 6, 2023, and found significant violations of current good manufacturing practice (CGMP) requirements (21 CFR parts 210 and 211) in the manufacture of investigational new drugs and biological products, CT053 and CT041. These products, used in a Phase 2 study, are deemed adulterated under section 501(a)(2)(B) of the FD&C Act, leading to prohibited acts under sections 301(k) and 301(a).

Key violations include: 1. **Facility Maintenance (21 CFR 211.56(a)):** Failure to maintain a clean and sanitary facility, evidenced by scuttle fly pupae and larvae found in the mechanical room and cleanrooms in July 2023. 2. **Aseptic Processing Control (21 CFR 211.42(c)(10)(iv), 211.113(b)):** Lack of non-viable particulate and viable microbial active air monitoring during open manufacturing manipulations in the Grade (b)(4) aseptic processing area. 3. **Cleaning and Disinfection (21 CFR 211.42(c)(10)(v