FDA 483 - Algunas Inc., dba Woodland Hills Compounding Pharmacy - April 29, 2016

During an FDA inspection from April 25-29, 2016, Algunas Inc., operating as Woodland Hills Compounding Pharmacy, was cited for several significant quality control deficiencies. The inspection, documented in an FDA 483, identified three main observations indicating non-compliance with manufacturing regulations. Firstly, the pharmacy's procedures for handling drug product complaints and adverse drug events were found to be inadequate. There was no systematic review or maintenance of complaint files, and employee training procedures did not require reporting of adverse events or documentation of communications with medical providers or patients. Secondly, the firm failed to thoroughly investigate unexplained discrepancies and batches that did not meet specifications. They lacked a formal procedure for investigating failed batches, did not maintain a log of such incidents, and often omitted root-cause analyses. Furthermore, the pharmacy utilized non-validated test methods from a third-party laboratory for critical drug product potency testing. Finally, observations highlighted issues with equipment calibration. A pH meter lacked independent calibration and proper controls for temperature variation, and its calibration records were not logged for trend monitoring. An expired calibration standard was also in use. These observations underscore the necessity for Woodland Hills Compounding Pharmacy to implement comprehensive corrective actions to ensure adherence to regulatory standards for drug manufacturing.