A California drugmaker has been eviscerated in an FDA warning letter after inspectors found it using “kitchen cooking pots and household power tools” to manufacture a drug for vaginal use to stop bleeding after cervical biopsies.
The FDA says the drug was produced under filthy conditions by BioDiagnostic International at its plant in Brea, California.
BioDiagnostic has recalled all of its products, which are distributed by MedGyn Products, of Addison, Illinois, but the FDA has warned healthcare professionals to avoid them. The agency said there have not been any reports so far of adverse events.
The FDA during its inspection in January noted the company’s manufacturing area was open to the outdoors and included an area for employees to prepare their own food.
“During the inspection, our investigator observed filthy conditions in your facility, including dirty equipment and utensils covered with unknown residue. ...The insanitary conditions observed at your facility failed to protect drug products from contamination with filth.”
The FDA noted the plant was not routinely testing the solution for microbial contamination. While the company offered explanations and said it intended to make improvements such as hiring a “professional cleaning crew,” the FDA was not impressed. It suggested the drugmaker hire a professional consultant if it intended to continue to produce drugs at the plant.