FDA WARNING_LETTER - Steiner Biotechnology, LLC - June 28, 2019

On February 3, 2020, the FDA issued a Warning Letter to Steiner Biotechnology following an inspection from June 24-28, 2019. The inspection assessed compliance with nonclinical Good Laboratory Practice (GLP) regulations (21 CFR Part 58) for studies involving the Skeletal Graft and Ridge Graft devices.

The letter identified serious violations, including: 1. **Failure to follow study protocols (21 CFR 58.130(a)):** Repeated, multiple surgeries were performed on the same animals, and some animals were used across both studies, neither of which was stipulated in the protocols. This raised animal welfare concerns and introduced confounders. Additionally, anesthesia protocols were not followed, with only (b)(4) used instead of (b)(4) as specified, compromising animal welfare and data reliability. 2. **Inadequate Quality Assurance Unit (QAU) (21 CFR 58.35(b)(3) and 58.35(c)):** The QAU failed to properly document inspections, and there was no written documentation of QAU responsibilities and procedures, jeopardizing study integrity and data validity. 3. **Improper specimen identification (21 CFR 58.130(c)):** Specimens lacked proper identification, leading to potential errors in data recording and storage. 4. **Incomplete training and experience