MedPage Today
FDA inspectors issued violation notices to 28 compounding pharmacies after surprise inspections -- that is, nearly every pharmacy they visited that was producing supposedly sterile drugs. According to the agency, FDA inspectors recently performed 29 inspections at compounding pharmacies in 18 states believed to be selling sterile drug products. All but one resulted in "Form 483" notices listing deviations from safe drug production standards. Among the deficiencies: "Unidentified black particles floating in vials of supposedly sterile medicine", “Mold in clean rooms”, “Workers handling sterile products with their bare hands and wearing nonsterile lab coats”.
