Dive Brief:
- After visiting Cerno Pharmaceuticals' manufacturing facility in Miami, Florida in November 2017, the Food and Drug Administration has sent a warning letter listing significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals.
- The company's manufacturing does not conform to cGMP and the company has misbranded two of its products, Verruguin Wart Remover and Stamapro, according to the letter.
- The FDA stated that the company's response is inadequate and suggested changes that should be made in collaboration with a qualified consultant.
Dive Insight:
Miami-based company Cerno provides raw materials to the pharmaceutical industry; it also produces over-the-counter products such as Stamapro lidocaine spray and Verruguin Wart Remover (salicylic acid).
Cerno's cGMP violations focused around testing, cleaning and maintenance. In the manufacture of the wart remover, Cerno used salicylic acid before the lot had been tested and then stated that the test was pending; the company also said that it was manufacturing "at risk" and would pull the product if the test results were not positive. The FDA said that the response, which stated that a deviation report was being prepared and that staff were being trained, was deemed inadequate and that untested lots must be withheld from use until results were available. The FDA's request on this point is for analytical results and for future measures to be taken.
Cerno did not follow its own cleaning procedures, resulting in cleaning not being carried out to schedule. The company's response was that it would revise its procedures and train employees. This was deemed inadequate by the FDA because it did not include an assessment of the effect on product quality, and plans on how to prevent the issue in the future. The request on this point is for a revised cleaning procedure and details of training.
Cerno also combined cleaning and use logs for blending and filling equipment, and did not complete these adequately; its response was to submit the same logs again. The request from the FDA on this point is to request revised logs including more details, and controls to ensure these are completed correctly. To meet these cGMP violations, the FDA has recommended help from a qualified consultant.
The violations also included misbranding offenses. The Verruguin product included the claim "wart remover… for the removal of common warts" and the Stamapro spray stated "Male Genital Desensitizer... helps in the prevention of premature ejaculation." Because of these claims, these products come under the definition of drugs in the FD&C Act. However, they do not conform as their labeling is not complete in both English and a foreign language. They also do not include a domestic address and telephone number.
Cerno is required to respond within 15 working days.