FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Florida Compounder Snags Warning Letter for Adulterated Products

Nov. 15, 2018

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.

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