FDA cites sanitary issues at St. Louis-area pharmacy, 29 others - KMOV.com

FDA cites sanitary issues at St. Louis-area pharmacy, 29 others

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By Brendan Marks By Brendan Marks
By Brendan Marks By Brendan Marks

(KMOV) – Officials with the Federal Drug Administration found rust, mold and shoddy practices when it inspected 30 specialty pharmacies nationwide, including one in St. Louis.

Foundation Care in Earth City is one of a small group of specialty pharmacies across the country that mixes medicines, a process called compounding. FDA inspectors say workers failed to properly sterilize equipment and prevent bacteria from contaminating its medicines.

News 4 tried to talk with them face-to-face about the FDA report, but a company executive would only talk over the phone.

The inspections were launched by the FDA after a meningitis outbreak caused by tainted drugs was eventually linked to a Massachusetts company. During the outbreak, 53 people died and more than 700 got sick.

The pharmacist in charge at Foundation Care told News 4 over the phone the contamination problem involved injectable medicines.

He said his company doesn’t compound the drugs in question, so the risks level is much lower and that the FDA is unfairly holding companies like his to standards designed for major drug manufacturers.

The FDA found seven concerns at Foundation Care, including no in-house tests to check for sterility and potency after compounding. But the company said it hires outside testing labs to do that.

Foundation Care says the federal government virtually shut down its business for a week to do an inspection that found no egregious problems and that they meet or exceed all state and industry standards.

 

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