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 13, 2019
Researched List: Blister Machines for Life Sciences
Need a blister machine for life sciences packaging? Our curated list features companies serving pharmaceutical, medical device, nutraceutical, and cosmetic industries. Download to access company names, locations, machine specifications, descriptions, and more.
Download Now
Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
Learn More