American Optisurgical, an ophthalmic device company based in Lake Forest, Calif., received a 13-observation Form 483 after an inspection by Irvine, Calif., CDRH staff stretching from Jan. 30 to Feb. 23.
The devicemaker lacked procedures defining the responsibility for review, and establishing authority for the disposition of nonconforming products, according to the FDA’s Form 483.
Additionally there were insufficient procedures for receiving, reviewing and for evaluating complaints by a formerly designated unit.
Having a centralized location for your procedures is integral when the FDA pays you a visit.
Next time the FDA comes to your company, who is going to be in your war room and how should you determine assigned roles and seniority? What kinds of information should you provide — and what’s off limits to the FDA?
If you’re a drug- or devicemaker and cannot confidently answer these questions, clear your schedule this Tuesday for FDAnews’ Creating, Staffing and Managing an Inspection War Room.
This detailed webinar goes far above where those other basic “how to prepare for inspections” seminars peak. Too often, companies slap together what is essentially the central nervous system of their inspections. With Creating, Staffing and Managing an Inspection War Room, you will get the who, what, where, why and how behind every good inspection. Register today!