API repackager in hot water with FDA


A U.S. drug repackager is in hot water with the FDA, earning itself a warning letter by taking liberties with the expiration dates on the drugs it repackages and a having quality unit that pretty much shirked its responsibilities, even though the problems had been noted during inspections 5 years earlier.  

The warning letter to Apotheca Supply, which does business as Apothecares, was posted this week but hearkens back to an inspection done at the Decatur, AL, company in February 2015.

In it, the FDA said the company had extended the expiration dates on coenzyme Q10 USP, carprofen USP, bupivacaine HCL USP, ursodiol EP, and itraconazole EP, without any kind of sign off from the quality unit.


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In fact, the FDA said, the company’s quality unit failed to approve records or written standard operating procedures (SOPs) for processes like expiration date extension, material quarantine, product distribution and equipment cleaning.

The expiration dates were extended for APIs by as much as two years beyond those listed by the manufacturers without any scientific justification to do it and no stability testing that would insure the APIs would still be effective, the FDA said.

In addition, the agency was concerned about potential for cross contamination because of its procedures. It noted the company weighs and repackages APIs including hormones, tricyclics, muscle relaxants, non-steroidal anti-inflammatory drugs, antifungals and quinolones in non-dedicated suites using non-dedicated equipment.

On top of that the inspector found expired cleaning products and there had been no testing to ensure that surfaces were cleaned of one product before work began on another.

The company was told to do a risk assessment on the potential problems and report back to the FDA pronto.

Regulators take the risk of cross contamination at repackagers seriously. Last year, Health Canada closed repackager Attix Pharmaceuticals in Toronto and had it recall hundreds of bulk APIs that the regulators said could have been cross-contaminated by penicillin. The FDA also inspected that plant and issued a warning letter for it as well.

- here’s the warning letter 

Related Article: 
FDA warning letter lays out cross-contamination issues at Canada plant

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