GS Medical Packaging Warned Over Several Missing Procedures

GS Medical Packaging has received an FDA warning letter because it lacked several procedures, including an MDR procedure for its sterilization pouches. The company’s post-inspection response was not adequate because it submitted a document, “Recall of Nonconforming Product,” that turned out to be its process for device recalls, rather than an MDR procedure, according to the June 12 letter posted online Tuesday.
Devices & Diagnostics Letter