A recent FiercePharma article discussed regulatory action brought to Massachusetts-based drug repackager Lohxa. Apparently the company’s plant was repackaging unit dose drugs with expiration dates of 12 months from repackaging, but had no data to support the dates. Lohxa claimed to have data to support a six-month expiration date, but failed to produce the information. In addition to the expiration date debacle, the company was also dinged for a lack of data related to its equipment cleaning processes. The inspection of the plant happened earlier this year, but the information was only recently posted. The FDA insisted Lohxa resolve the issues as soon as possible.
Quick Hits: Lohxa in Hot Water for Arbitrary Expiration Dates on Packaging
The FDA slapped drug repackager Lohxa with a warning letter claiming its storage and equipment cleaning processes aren’t up to code.
Dec 13th, 2019