Compounding Pharmacy Gets Warning Letter

FDA issued a warning letter on May 23, 2016 to PCP LV, LLC dba Pinnacle Compounding Pharmacy, located in Las Vegas, NV. The warning letter cited violations observed during an FDA inspection conducted in July 2015. FDA cited the company for deficiencies in the production of sterile products.

Investigators observed, among other things, that environmental monitoring samples were incubated in a hallway at uncontrolled room temperature and an expired disinfectant was used. The company also did not have appropriate studies to assure that a hood provided adequate protection of the ISO 5 area where sterile products were processed, which poses a contamination risk. Other violations observed included not having an appropriately filtered air supply; not establishing an adequate cleaning and disinfecting system; personnel not wearing appropriate clothing to prevent contamination; and failure to perform appropriate stability testing.

At the time of the July 2015 inspection, the company was registered as an outsourcing facility under 503b of the Federal Food, Drug, and Cosmetic Act (FDCA). However, it is no longer registered as an outsourcing facility. Therefore, FDA states that it must meet certain conditions to qualify for the exemptions under section 503A of the FDCA. The warning letter states, “FDA strongly recommends that your management immediately 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. You should fully implement necessary corrections in order to ensure that the drug product(s) produced by your firm conform to the basic quality standards that ensure safety, identity, strength, quality, and purity.”