FDA Cites Florida Drugmaker for GMP Violations

The FDA hit Brooksville, Fla.-based Med-Nap with a Form 483 for lacking proper procedures to prevent product contamination.

An inspection of the drugmaking facility revealed problems with equipment design, including inadequately sealed tanks near sources of dust and a missing ceiling tile near a machine used for manufacturing.

The investigator also observed a maintenance employee making repairs while sitting on a conveyor belt without using a decontamination mat.