FDA 483 - Roger Williams Medical Center - August 14, 2019

From July 22, 2019, to August 14, 2019, the FDA inspected Roger Williams Medical Center's Oncology Pharmacy Clinic, a producer of sterile drugs, located at 50 Maude St, Providence, RI. The inspection resulted in seven observations issued to Susan C. Benfeito, Vice President of Quality, Risk and Performance Management.

Observation 1 noted inadequate product evaluation and remedial action for microbial contamination in areas adjacent to the ISO 5 aseptic processing area. Specifically, the firm failed to investigate or take action on "Irpex (mold)" found in the Chemo Room on May 13, 2019 (2 CFU/m3) and July 23, 2019 (3 CFU/m3), continuing production without root cause analysis or impact assessment. "Aspergillus fumigatus (mold)" (1 CFU/m3) and "Methylobacterium (bact, GNR)" (2 CFU/25cm) were found on August 8, 2018, with delayed response and no assurance against transfer from the Ante Room.

Observation 2 cited facility design allowing poor quality air into higher classified areas. This included an unclassified pharmacy area adjacent to ISO 7 Clean and Chemo Rooms with cluttered components, lacking assurance against air influx. The pressure differential gauge between the ISO 7 Ante Room and Chemo Room was not operating properly,