Compounding Pharmacy Warned for Sterile Manufacturing Violations

On June 9, 2016, FDA sent a warning letter to The Compounding Pharmacy of America, Knoxville, TN, citing the company for not having valid prescriptions for individually-identified patients. The company was also cited for deficiencies in the production of sterile products.

FDA stated that during a May 2015 inspection, FDA found that technicians preparing sterile drugs were not wearing proper gowning in addition to working in an unclassified room with no HEPA filtration. The inspectors also observed that the company did not use a sporicidal agent as part of the disinfection program for the aseptic processing areas. The warning letter states that the company “failed to demonstrate through appropriate studies that your hoods are able to provide adequate protection of the ISO 5 area in which sterile products are processed.  Therefore, your products may be produced in an environment that poses a significant contamination risk.” 

The company was cited for the production of unapproved new drug products and for the misbranding and adulteration of drug products. The warning letter stated, “You compound drug products for which you have not obtained valid prescriptions for individually-identified patients that are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses.”

FDA stated that some of the company’s corrective and preventive actions are adequate but “the remaining proposed corrective actions either cannot be fully evaluated as your firm did not provide supporting documentation or appear to be deficient.” The agency recommends the company “undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation.”

Source: FDA