Steiner Laboratories – FDA Warning Letter, Dec 16, 2016

This FDA Warning Letter to Steiner Biotechnology, LLC, dated June 21, 2017, details objectionable conditions observed during an inspection from December 12-16, 2016. The inspection assessed compliance with federal regulations for significant risk (SR) clinical studies of Ridge Graft and Skeletal Graft devices, defined under 21 U.S.C. § 321(h).

The FDA identified serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects). Key violations include:

1. **Failure to submit IDE application and obtain FDA/IRB approval:** Steiner Biotechnology conducted investigations on Ridge Graft and Skeletal Graft, which are SR devices requiring IDE approval, without submitting an IDE application to the FDA or obtaining IRB approval. This was despite prior FDA communications regarding these requirements. 2. **Failure to maintain accurate, complete, and current records:** The company failed to maintain essential records, including study protocols, subject enrollment logs, inclusion/exclusion criteria, and signed informed consent documents. 3. **Failure to obtain informed consent:** Informed consent was not obtained in accordance with 21 CFR Part 50. The informed consent document used lacked all required basic elements (21 CFR 50.25) and was not IRB-approved.

The FDA disagreed with Steiner's assertion that their activities did not