Osseofuse International Inc. – FDA 483, Jan 7, 2026
An FDA inspection of Osseofuse International Inc., a specification developer of sterile and non-sterile dental implants and abutments in Las Vegas, NV, revealed significant deficiencies in their quality system. Observations included inadequate procedures for finished device acceptance, specifically regarding sterility verification and record-keeping, as well as undocumented evaluations of contractors. Additionally, the firm lacked established procedures for design changes, leading to uncontrolled documentation of approvals.
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