Eminent 483 Notes Validation, Lack of Documented Procedures

Eminent Spine received a Form 483 after the FDA found its cleaning instructions for intervertebral body fusion systems were not validated to show the procedure is capable of removing contaminants, such as body fluids, from the instruments.

A March inspection of the Georgetown, Texas, company also found it had not established procedures for the acceptance activities for its systems after they had been used in surgery.

Eminent also did not have a procedure or quality agreement to define supplier responsibilities and had not conducted a formal, documented internal audit, the form says.
The GMP Letter