Regulatory Focus™ > News Articles > Troubling Sterility Lapses Found at Compounding Facility

Troubling Sterility Lapses Found at Compounding Facility

Posted 29 October 2012 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has identified a number of troubling lapses in good manufacturing practices at the New England Compounding Center (NECC), the Massachusetts-based pharmaceutical compounding facility now linked to a massive outbreak of fungal meningitis, after an inspection revealed widespread and unaddressed sterility problems.

Regulators released a Form 483, a form FDA uses to list potential violations of the Federal Food, Drug and Cosmetic Act, on 26 October 2012. In an accompanying press release, FDA said its investigators had "observed problems with NECC's ability to maintain its clean room"-a room used to manufacture products in sterile conditions.

A Not-so-"Clean" Room

According to the inspection report, records from the facility indicated a long-running series of sterility issues in the clean room, including 11 separate instances of bacteria and three instances of mold being found within production hoods.

"These results were not investigated and there was no identification of the isolates," explained FDA. "There were no product impact assessments performed for any sterile products that were made in the hoods or glove boxes on the days the samples were taken."

In other words, NECC did not check to see if any of the products manufactured before the mold and bacteria were discovered had been contaminated.

"In addition," continued FDA, "the firm has no evidence that any corrective actions were taken to prevent contamination of the sterile drug products."

Products affected by the contaminated included Avastin, Mafenide Acetate, and at least three undocumented products.

Sterile Manufacturing Lapses

The facilities' sterile manufacturing equipment also had other troubling lapses, wrote FDA. Investigators found "white, filamentous substances" and condensation within one of NECC's autoclaves, used to sterilize formulated bulk drug suspensions. Other production hoods were found to be contaminated with yellow and green residues, presumably mold or bacteria, and interviews with NECC staff found an air conditioning unit meant to control the temperature of the clean rooms was turned off nightly. More hot and humid conditions would presumably create a more favorable environment for bacteria, mold and fungus to grow.

Even the facility itself was not positioned appropriately, said investigators. One hundred feet behind NECC's compounding facility is a recycling operation managed by the same owners of NECC's facility. This operation, which includes heavy machinery, generates large amounts of particulate matter, which is likely to make its way into the facility through the facility's HVAC system, said regulators.

Investigators said they discovered 83 vials of methylprednisolone acetate, a supposedly sterile injectable drug, containing a "greenish black foreign matter," and an additional 17 vials containing a "white filamentous material." Contaminated vials of the same drug have been linked to the deaths of at least 25 individuals and the infections of hundreds of patients with fungal meningitis, and regulators have previously said that it was clear that the contamination had originated at the NECC facility. 

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