FDA Cites Sanitary Issues at Specialty Pharmacies
WASHINGTON (AP) — The Food and Drug Administration says it has uncovered troubling sterility problems at 30 specialty pharmacies that were inspected following a recent outbreak of meningitis caused by contaminated drugs.
The agency said its inspectors targeted 31 compounding pharmacies that produce sterile drugs, which must be prepared under highly sanitary conditions.
In an online posting Thursday, the FDA said it issued inspection reports to all but one of the pharmacies listing problems, including: rust and mold in supposedly sterile rooms, inadequate ventilation and employees wearing non-sterile lab coats.
The inspections were conducted between February and April in response to a deadly fungal meningitis outbreak linked to contaminated steroids. The injections from a Massachusetts pharmacy have caused 53 deaths and 733 illnesses since last summer.