FDA 483 - Steiner Biotechnology LLC - November 08, 2022

An FDA inspection of Steiner Biotechnology, LLC, a medical device manufacturer, was conducted from November 3 to November 8, 2022. The inspection revealed multiple significant deficiencies in the company's quality management system, indicating non-compliance with the Federal Food, Drug, and Cosmetic Act concerning medical device regulations.

Key violations included a lack of established and documented procedures for design control, specifically regarding validation and verification for their OsseoConduct bone grafting material. The firm's risk analysis for OsseoConduct was found inadequate, failing to identify foreseeable hazards. Critical sterilization processes for products like Oral Bond Dental Adhesive, Socket Graft, and OsseoConduct were not validated. There were also failures to adequately evaluate and monitor suppliers for critical materials, establish comprehensive device history records with acceptance criteria, and ensure accurate labeling. Equipment calibration, particularly for the OsseoConduct sterilization unit, was not routinely performed. Environmental controls in cleanrooms were insufficient, with concerns about potential particulate contamination and inadequate personnel gowning procedures. The company had not conducted required quality audits nor adequately evaluated product complaints for Medical Device Report (MDR) reportability. Several of these issues were repeat observations from a prior inspection, highlighting persistent systemic problems.

Steiner Biotechnology, LLC is required to implement thorough corrective actions to address these fundamental quality system failures and achieve full regulatory compliance.