FDA WARNING_LETTER - Eminent Spine, LLC - March 09, 2010

On March 1-9, 2010, an FDA inspection of Eminent Spine, LLC, a manufacturer and distributor of Intervertebral Body Fusion Systems (IBFS), revealed that their devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

The inspection resulted in a Form FDA-483 listing significant violations. Eminent Spine's March 29, 2010, response was deemed incomplete as it lacked documentation of completed and verified corrective actions.

Key violations include: 1. Failure to establish and maintain procedures for nonconforming products (21 CFR § 820.90(a)), as evidenced by acceptance of Copperhead implants exceeding dimensional specifications without proper evaluation or justification. 2. Failure to establish and maintain adequate procedures for finished device acceptance (21 CFR §§ 820.80(d) and (e)), specifically lacking procedures for inspection and cleaning of returned surgical instruments and unused implants, with observations of residue on returned devices. 3. Failure to establish and maintain procedures for validating device design (21 CFR § 820.30(g)), including lack of validation for multiple autoclave sterilization cycles on IBFS devices and failure to validate the cleaning procedure