FDA WARNING_LETTER - INCELL Corporation LLC - September 29, 2023

The FDA inspected INCELL Corporation LLC from September 25-29, 2023, regarding its amniotic fluid-derived product, (b)(4), manufactured for (b)(4). The FDA determined (b)(4) is an unapproved new drug and an unlicensed biological product, violating sections 505(a) and 301(d) of the FD&C Act, and 351(a)(1) of the PHS Act. The product is also adulterated under section 501(a)(2)(B) of the FD&C Act due to significant CGMP violations (21 CFR parts 210 and 211), and misbranded under section 502(a) of the FD&C Act.

Key violations include: 1. **Failure to validate aseptic processes:** No validation (e.g., media fills) since manufacturing began in February 2020, despite the product purporting to be sterile. 2. **Inadequate laboratory controls:** No scientifically sound specifications for identity testing of the finished product. 3. **Lack of stability testing program:** Expiration dates (b)(4) and (b)(4) are assigned without supporting stability data.

Misbranding issues include misleading labeling regarding the product's form and unsupported expiration dates. The FDA also raised concerns about environmental monitoring in the manufacturing environment and inquired about