The FDA has slapped around a U.S. drug repackager, saying in a warning letter that its storage processes and equipment cleaning are not up to expectations.
The warning letter for Worcester, Massachusetts-based Lohxa criticized the plant for giving lots of repackaged unit dose drugs, including pneumonia treatment atovaquone oral suspension, expiration dates of 12 months from repackaging but had no data to support the dates.
The company claimed to have data to support a six-month expiration date, but the FDA said it never made the information available.
The inspection of the plant occurred earlier in the year but was only recently posted.
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On the cleaning front, the Lohxa plant had no data to back up its equipment cleaning processes. The FDA pointed out that one machine is used to fill different drugs into unit dose containers, including the highly potent API atropine, but could not provide protocols to show the equipment was cleaned thoroughly enough to prevent cross-contamination.
Finally, the inspector found no indication that the plant had carefully investigated consumer complaints about leaking cups to find a cause. The agency says managers couldn’t even show how the complaint was received.
The FDA wants Lohxa to upgrade all of those processes and resolve the issues ASAP.
These kinds of issues with a repackager are not new. In 2017, an FDA warning letter was issued for the Decatur, Alabama, plant of API repackager Apothecares. In that case, the facility was cited for extending the expiration dates on a number of drugs without the plant’s quality unit signing off on the change.