FDA Inspection Blitz Reveals Weakness in Sterile Practices at Large Compounders

A review of the initial results from an inspection blitz of about 30 high-volume sterile pharmacy compounding operations nationwide launched by FDA in late February shows a clear pattern of weakness in their sterile practices including environmental monitoring, gowning, personnel practices and sterility/endotoxin testing.

Two weeks into the blitz, FDA had already posted 14 extensive 483 observation reports stemming from completed inspections.

The inspection initiative was launched by FDA in the wake of the findings of out-of-control sterile practices at the New England Compounding Center (NECC) that resulted in the nation-wide fungal meningitis outbreak (see IPQ’s Special Report on “The Current Crisis in Pharmacy Compounding and its Implications” and follow-up coverage cited below).  The recurrent problem areas highlighted in the 483s were also salient at NECC and its sister company Ameridose.

FDA has selected the sterile compounders to inspect based on the size of their operations and the extent of their distribution networks, along with an analysis of adverse event reports, historical inspection data, reports of quality problems, and public information. The inspections are being conducted in conjunction with state regulatory agencies.

The 14 483s list deficiencies across the gamut of aseptic practice, with some strong commonalities including: ● gowning concerns (12) ● personnel practices (10) ● environmental monitoring (9) ● sterility/endotoxin testing (7) ● media fills (6) ● investigations (5), and ● sterilization validation (5) (see box below).

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See related IPQ stories:

Letter from CDER’s Woodcock to PharMEDium Serves as Notice to Compounders and Hospitals on Need for Product/Patient Linkage

Debate Continues Among Stakeholders on Framework for Regulating Pharmacy Compounding; Legislative Options Reviewed at FDLI Forum

Iowa, Massachusetts, California and Virginia Intensify Compounding Pharmacy Crackdown

Mass. Closes More Compounders; Grand Jury Probes NECC; New Infection Types Reported; FDA Reaches out to States

Congressional Hearings Expand Meningitis/NECC Probe; More Light Shed on Regulatory Gaps

FDA Inspection Findings of Sterile Practice Breeches at Ameridose Mirror Those at NECC

Special Report on The Current Crisis in Pharmacy Compounding and its Implications