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FDA inspections of compounding pharmacies result in FDA-483 citations.
In an FDA blog, FDA Commissioner Margaret Hamburg stated that recent FDA inspections of 31 compounding pharmacies known to produce sterile drugs resulted in a discovery of inappropriate sterile-manufacturing conditions and FDA-483 observation results for all but one of the companies inspected. The companies were cited for incidents ranging from rust and mold in cleanrooms to unidentified black particles in vials of sterile product. Some of these FDA-483 notices have led to voluntary product recalls.
According to Hamburg, FDA was met with resistance from some of the pharmacies that were included in the inspections. She claims that some inspections were either delayed or inspectors were denied full access to records, thus requiring court-issued warrants. “These inspectional observations reveal that there continues to be reason for concern about sterility deficiencies and other problems in some compounding pharmacies across the country–problems that could potentially affect the health of patients. To carry out this proactive inspection effort, FDA had to shift resources from other areas, and this is not a sustainable approach for the longer term,” Hamburg stated on FDA.gov.
Hamburg also stated that FDA is working with Congress on legislation for FDA oversight of compounding pharmacies and is evaluating the agency’s surveillance and enforcement approach.