Stratus BioSystems, LLC – FDA Warning Letter, Feb 28, 2019

The FDA issued a Warning Letter to Stratus Biosystems, LLC, following an inspection from February 6-28, 2019, identifying significant deviations from 21 CFR Part 1271 regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. **Failure to validate processes:** The Amniotic Membrane Patch Allograft manufacturing process was not adequately validated to ensure contamination removal and prevent communicable disease transmission, despite products being distributed since March 2018. (21 CFR 1271.230(a)) 2. **Distribution of non-conforming HCT/Ps:** Products were distributed from a donor with a positive pre-processing culture for *Staphylococcus aureus* (a Class 3 organism requiring discard) and from a donor with a positive post-processing culture for *Clostridium perfringens* on a different product from the same donor. (21 CFR 1271.265(c)(2)) 3. **Failure to determine and document donor eligibility:** Since March 2018, the firm failed to document donor eligibility based on screening and testing results. (21 CFR 1271.50(a)) 4. **Failure to retain donor eligibility records:** All Amniotic Membrane Patch Allograft products distributed since February 2018 lacked a statement of