Florida Outsourcing Facility Violates FDA’s Requirements

A Florida-based drug compounder failed to qualify as an outsourcing facility because it produces only non-sterile drug products.

The FDA faulted Sincerus Florida LLC of Pompano Beach, Fla., in a warning letter, posted online Feb. 7. The letter is part of the Food and Drug Administration’s stepped-up enforcement efforts in the drug compounding area; in 2016, the agency sent more than 40 warning letters to drug compounders.

In response to a 2012 fungal meningitis outbreak associated with injectable drugs produced by a compounding facility, the Drug Quality and Security Act of 2013 gave the FDA more ...