STORZ SURGICAL OPHTHALMIC PACK STERILITY PROBLEMS
This article was originally published in The Gray Sheet
Executive Summary
STORZ SURGICAL OPHTHALMIC PACK STERILITY PROBLEMS cited by FDA in a recent warning letter to the company. The agency lists 17 violations of good manufacturing practices regulations, most of them related to product sterility. The letter follows a March 14 through May 25 inspection of the company's St. Louis production plant.