FDA 483 - Maple Rose Enterprises, Inc, dba Pencol Pharmacy - August 22, 2016

An FDA inspection of Maplerose Enterprises LLC, operating as Pencol Pharmacy, a producer of sterile and non-sterile drugs in Denver, CO, was conducted from August 8 to August 22, 2016. The inspection revealed significant deviations from current Good Manufacturing Practices (cGMP), particularly impacting sterile drug production. Key issues included poor facility maintenance, such as compromised cleanroom integrity, and a complete absence of environmental monitoring during aseptic processing. The firm failed to perform routine calibration for critical equipment like analytical scales and temperature/humidity monitors, compromising quality assurance. Deficiencies were also noted in cleaning and disinfection practices, with unvalidated sterilization cycles and incorrect sporoidal treatment. Furthermore, Pencol Pharmacy lacked established procedures to prevent microbiological contamination, demonstrated by the absence of bubble point testing, dynamic smoke studies, and the use of non-depyrogenated equipment for sterile injectables. Inadequate gowning practices, a non-existent written quality control unit, and a lack of defined responsibilities for material approval, equipment maintenance, and process controls were cited. The company also failed to implement a stability testing program, relying on unvalidated potency analyses for setting Beyond Use Dates, and did not conduct microbiological testing on incoming components or comprehensive identity and potency testing on all finished sterile products before release. Corrective actions are required to address these systemic failures and ensure drug product quality and patient safety.