FDA intends to continue proactive and for-cause inspections of compounding
pharmacies, and FDA plans to take aggressive action, including enforcement
actions, as appropriate to protect the public health.
For the past year, since the fungal meningitis outbreak began, FDA has been
conducting inspections of compounding pharmacies for cause (in response to
serious adverse event reports and reports of quality problems) and proactively
to identify pharmacies with deficient sterile compounding practices. Using a
risk-based model, we identified 29 firms for priority inspections focused on
their sterile processing practices. FDA identified secondary firms associated
with two of these inspections, for a total of 31 firms. Between October 1, 2012
and October 31, 2013, FDA completed 42 for-cause inspections in addition to the
31 proactive inspections.
When we identified problems during any of these inspections, we issued a Form FDA-4831 listing our inspection observations. We have issued a Form FDA-483 at the majority of the inspections we have conducted since the fall of 2012. As these Form FDA-483s reflect, we observed serious quality problems, including contaminated products and sterile practices that create a risk of contamination. Numerous recalls2 of sterile products have been conducted, and numerous pharmacies chose to stop sterile compounding after we identified problems with their sterile compounding processes. New problems continue to be identified at compounding pharmacies across the country, and FDA intends to continue its inspection and enforcement efforts to address these problems, using currently available resources. For oversight of outsourcing facilities registered under section 503B, FDA will use fees assessed and collected from those facilities in accordance with the law to supplement other agency resources.
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