Two More Compounders Warned for Poor Sterile Manufacturing

June 18, 2015

Compounding pharmacies continue to be plagued by sterility issues, as the FDA handed warning letters to facilities in Florida and Kentucky — bringing to nine the number of compounders cited for such deficiencies since October.

In an April 27 letter, the FDA faulted Absolute Pharmacy for monitoring particulates only once since registering as an outsourcing facility.

And in an April 29 letter, the FDA warned Vann Healthcare Services for producing sterile drugs while skin was exposed. Both firms’ equipment hoods were deemed inadequate.

Vann no longer compounds sterile drugs. Absolute did not respond to a request for comment.

Poor microbial contamination control is now a top Form 483 observation. The focus to date has been on compounding pharmacies, but no FDA- or EU-regulated manufacturer is exempt from its country’s purity laws. Stay safe with FDAnews’ Manufacturing Sterile Products to Meet EU and FDA Guidelines.