Chronic Lack of Quality Testing Leads to FDA Alert for Compounder

The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests.

The agency issued a July 19 safety alert on drugs compounded by Downing Labs and its subsidiary Nuvision Pharmacy following a June to July inspection of the compounder’s facility that found the lots failed sterility or endotoxin tests from April 2013 to June 23, 2014. “In each case, the investigations were either absent or incomplete,” says a Form 483 issued July 16.

Downing’s contract laboratory determined that a lot of folic acid 10 mg and two lots of cyanocobalamin 1 mg/ml failed sterility and were contaminated by bacteria. However, no investigation was performed as to how the lot failed sterility, says the 483 with 15 observations.

All of the lots were destroyed except for two, with a lot of cyanocobalamin awaiting distribution after being re-tested for sterility and endotoxins. A lot of folic acid is being held in quarantine pending destruction, the FDA says.

The investigator also found that Downing didn’t do endotoxin testing on approximately 180 lots from April 2013 to June 2014.

Downing’s subsidiary Nuvision has tangled with the FDA before, rejecting a request from the agency last summer to recall questionably sterile products. The pharmacy noted at the time that it follows U.S. Pharmacopeia standards for compounders.

Downing did not return a request for comment as of press time.

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