FDA says microbial contamination found at Montana Compounding

Being able to take your dogs to the office may be a perk at some workplaces, but the FDA doesn't think it is such a great idea for a compounding pharmacy. So says an FDA warning letter posted this week for a compounder, another action in the FDA's effort to bring up the standards of that industry.

The warning letter was issued to Montana Compounding Pharmacy and Wellness Center in Missoula, MT, which last year had been issued a Form 483 following an inspection in which FDA sampling turned up "microbial contamination, including spore-forming bacteria and mold."

That was not a big surprise given that the facility was not adequately designed for sterile drug production, with issues such as carpeted floors just outside the clean room in an area with a pet bed and portable fence where the co-owner sometimes kept her dogs. The inspectors also noted the facility had never performed environmental monitoring and wasn't using a sporicidal agent or sterile wipes to disinfect the work surface where aseptic processing occurred.

The actions are part of the FDA's stepped-up oversight over compounders since getting additional powers from the Drug Quality and Security Act passed in 2013 following a fatal outbreak of meningitis tied to a compounder that was not following sterile practices. Its actions have included both large and small compounders.

Just this week, Abbott's Compounding Pharmacy began a voluntarily recall of all unexpired lots of sterile compounded products due to concerns of lack of sterility assurance "after a series of onsite inspections by the FDA," it said.

And earlier this month, a federal judge issued a consent decree against Downing Labs of Dallas, its co-owners Ashley Michelle Downing and Christopher Van Downing, and pharmacist-in-charge Roger Mansfield. The FDA sought the action against Downing Labs, formerly known as NuVision Pharmacy, saying the company had continued to manufacture adulterated drugs even after repeated warnings from the agency.

- read the warning letter
- Abbott Compounding Pharmacy recall

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