The FDA hit Pompano Beach, Florida, compounder Vital Rx with a warning letter for manufacturing deficiencies that resulted in adulterated drug products and potential risks for patients.
The agency during a June 26 to July 20, 2017 inspection observed drugs produced under insanitary conditions, risking contamination, with multiple violations involving a laminar flow hood where drug production occurred. In one instance, the firm didn’t use a sporicidal agent to disinfect the hood.
The investigator noticed the hood’s horizontal air vent — through which first air passes — was visibly stained. The facility also failed to sufficiently clean work surfaces and reusable equipment to deter cross-contamination, or to confirm that the glass vials it filled with injectable drug products were sterile.