FDA WARNING_LETTER - Steiner Biotechnology, LLC - November 08, 2022
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The FDA issued a Warning Letter to Dr. Steiner on May 19, 2023, following inspections on August 15-19, 2022, and November 3-8, 2022, at 1051 Olsen Street, Suite 3611, Henderson, NV 89011. The firm manufactures bone grafting materials, including Socket Graft, OsseoConduct, and others, which are classified as devices.
The inspections revealed that the devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(o) and § 352(t)(2) for lacking premarket approval/clearance and Unique Device Identifiers (UDI).
Key violations include: 1. **Failure to establish and maintain adequate design control procedures (21 CFR 820.30(a))**: Lacking procedures for design output, reviews, verification, validation, transfer, changes, and risk analysis. This is a repeat observation. 2. **Failure to validate processes (21 CFR 820.75(a))**: Specifically, sterilization processes for Oral Bond, Socket Graft, and OsseoConduct
ID · 34bfb97b-7e7a-4e2f-860e-dfa87670b124
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