The Food and Drug Administration conducted surprise inspections of four national compounding pharmacies that uncovered safety and quality issues at each facility just months after contaminated compounded drugs led to a meningitis outbreak that resulted in 48 deaths.
The inspected facilities were: AnazaoHealth Corp. in Tampa, Fla.; Chicago-based Central Admixture Pharmacy Services, also referred to as CAPS; Lee Pharmacy in Fort Smith, Ark.; and Pharmedium Services in Cleveland, Miss. None of the companies immediately responded to requests for comment. The effort is part of the FDA's campaign to conduct proactive investigations into pharmacies that undertake high-risk sterile compounding, said Erica Jefferson, an FDA spokeswoman.
The agency plans to inspect 30 facilities over the next two months. It has already conducted inspections in 11 states, and another batch of inspections reports, which are called FDA Form 483s, is expected to be released next week. This round of inspections occurred the week of Feb. 18. The reports mention a range of issues
, such as using dirty rags, problems with air monitoring, failures to recognize and address quality deficiencies in a timely matter, and a lack of endotoxin testing on finished sterile drugs.
Most hospitals purchase drugs from compounding pharmacies, a practice that has come under scrutiny since the meningitis outbreak was first reported in October.
New England Compounding Center, the pharmacy responsible for producing the tainted steroid injections, and Ameridose, a national compounder that shares ownership with NECC, have since closed. The FDA and state boards of pharmacy are seeking ways to better regulate compounding pharmacies that act more like drug manufacturers than traditional local compounding pharmacies.
The FDA's inspection into NECC yielded descriptions of contaminated products and unclean rooms
The FDA and state boards of pharmacy are currently seeking ways to address how to regulate nontraditional compounding pharmacies that act more like drug manufacturers than traditional local compounding pharmacies.