FDA 483 - Medical Center Pharmacy, Inc. - April 09, 2020

During an FDA inspection conducted between March 9 and April 9, 2020, Medical Center Pharmacy, Inc., a producer of sterile and non-sterile drug products, received an FDA Form 483 citing multiple significant observations related to manufacturing practices. The inspection revealed critical issues impacting the sterility and quality of their drug products.

Key observations included widespread non-microbial contamination within ISO 5 classified aseptic processing areas, characterized by dirty surfaces, chipped paint, and structural deficiencies like unsealed caulk and gaps. The firm was also cited for using non-sterile disinfecting agents and cleaning wipes in these critical areas, a repeat observation. Furthermore, the pharmacy failed to adequately evaluate and remediate instances of microbial contamination detected through environmental monitoring, including Bacillus, Staphylococcus, and various fungi, without proper rigorous cleaning or re-sampling.

Serious concerns were raised regarding the assurance of product sterility, specifically the lack of bacterial endotoxin testing for intrathecal drug products compounded from non-sterile active ingredients, and inconsistent expiration dates without supporting stability data. Critical equipment, such as air pressure gauges for aseptic processing, had not been calibrated since 2015. Media fills did not adequately simulate challenging production conditions, and HEPA filter coverage and airflow were compromised by structural defects. Additionally, the firm failed to disinfect equipment and materials prior to their entry into aseptic processing areas. Finally, inadequate controls for hazardous drug manufacturing posed a significant cross-contamination risk, compounded by insufficient sterilization parameter validation. The company is required to promptly address these deviations from Good Manufacturing Practices.