FDA 483 - PCP LV LLC dba Pinnacle Compounding Pharmacy - July 31, 2015

During an FDA inspection from July 27-31, 2015, PCP LV LLC, operating as Pinnacle Compounding Pharmacy, an outsourcing facility in Las Vegas, NV, was cited for significant deficiencies. The FDA 483 document highlighted numerous violations primarily concerning sterile drug production and quality control. Key issues included a lack of appropriate personnel gowning, with non-sterile attire and exposed skin observed during aseptic processing. The firm failed to establish and follow critical procedures to prevent microbiological contamination, such as validating sterilization processes, implementing a robust media fill program, or qualifying personnel for sterile operations. Environmental and personnel monitoring in controlled areas was deficient, lacking regular sampling during production and written procedures. Furthermore, the company did not consistently test every batch of sterile product for sterility and pyrogens, and their contract laboratory withheld crucial documentation. The Quality Control Unit lacked written responsibilities and procedures, and the firm failed to thoroughly investigate batch failures, including failed tests and product spills. Deficiencies extended to cleaning and disinfecting aseptic areas, inadequate air pressure monitoring, and a complete absence of a stability testing program to justify product Beyond Use Dates for Testosterone Cypionate and Gentamicin solutions. Finally, many drug product labels did not include information mandated by section 503B(a)(10)(A) and (B) of the FD&C Act, such as "compounded drug" statements, facility details, expiration dates, and storage instructions. Pinnacle Compounding Pharmacy is required to implement comprehensive corrective actions to address these serious non-compliance issues.