FDA Releases Results of 483 Inspections of Compounders; Contemplating Enforcement Proceedings

The FDA has released an announcement regarding its recent inspections of 31 sterile compounding pharmacies across the United States. The purpose of these inspections 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. As a result of these inspections, the FDA has issued a list of inspectional observations, called an FDA Form 483, to 28 of the 31 compounders. Some observations of the FDA include: incomplete and/or inadequate drug product batch failure investigations, inappropriate and/or inadequate clothing for sterile processing, lack of appropriate air filtration systems, insufficient microbiological testing, and other practices that create risk of contamination. The FDA is currently evaluating the information obtained during the inspections. For compounders operating outside the bounds of traditional pharmacy compounding and who had significant sterile production issues, the FDA plans to take aggressive action, including commencing enforcement actions.

The press release also contains a link to the list of compounders that were inspected.

We will continue to monitor these inspections and let you know of any developments, including whether the FDA commences any enforcement proceedings. If you have questions regarding FDA inspections, contact Frier Levitt to speak to one of our attorneys.