Intravenous news: The FDA report “The agency recently took a critical look at our surveillance and enforcement approach to pharmacies that produce sterile drug products. The agency’s objective was to determine whether certain pharmacies that were known to have produced high-risk sterile drug products in the past posed a significant threat to public health from poor sterile drug production practices.
Using a risk-based model, FDA identified 29 firms for priority inspections that focused on their sterile drug production practices. During these 29 inspections, in two instances, FDA identified secondary firms associated with the initial priority inspections, which it then inspected, for a total of 31 firms. Criteria for FDA’s risk-based model included serious adverse event reports, historical inspection data, and reports of product quality problems. Facilities that met at least two criteria or had a reported death were identified for the priority inspections. The inspections took place over a seven week period from February to April 2013. The Agency inspected these firms according to federal standards regarding aseptic practices.