The FDA slammed Cerno Pharmaceuticals for producing adulterated drugs at its Miami, Florida facility.
During a November 2017 inspection, the agency’s investigator found that the firm’s product, Verruguin wart remover, was manufactured using a salicylic acid before the component was tested and released for use by the quality unit.
In its response to the inspection observations, the firm said it would create a deviation report for using raw material before final release and train its staff in deviation reporting. But the agency said this was inadequate, noting that manufacturing drugs with untested components violates good manufacturing practices.
“Reporting such incidents as deviations will not mitigate the failure to ensure that raw materials are withheld from use until they have been tested or examined, and then released by the quality unit,” the agency said.
The firm also failed to follow its equipment cleaning procedures. Major equipment was supposed to be wet cleaned on a set schedule, but the firm’s filling room records showed it did not perform the required cleanings.
The company said it would revise its procedures to ensure a major cleaning takes place before production if the equipment has not been used for an extended period, but the agency was not satisfied with this response.
“You failed to assess the effect of this deficiency on product quality. You also did not include your plan for how you will prevent this deficiency in the future,” the agency said. “In addition, your response…failed to define ‘extended period of time.’”
The FDA also noted that the facility did not have adequate equipment use logs for its blender and filler used to manufacture liquid products. It used combined “Room/Equipment Cleaning and Use Logs” to document cleaning and use, but the logs did not document who performed what operations and when.