FDA 483 - Infusience Inc - April 25, 2018

The FDA Form 483 documents observations from an inspection of an aseptic processing facility. The facility operates ISO 5 classified aseptic processing areas for compounding various prescription drugs, including TPN, Ertapenem, Rifampin, Methylprednisolone, Azithromycin, Ceftriaxone, and Vancomycin.

Multiple violations related to quality systems and manufacturing practices were observed. On April 18, 2018, a large area of brown residue was found on the HEPA filter grate of an ISO 5 hood, with firm management unable to identify its nature or source. Personnel exhibited rapid hand movements during sterile production on April 17, 2018, disrupting airflow and increasing contamination risk in the ISO 5 area. Aseptic manipulations on April 18, 2018, blocked first-pass air around exposed sterile connections.

Furthermore, materials were not disinfected before entering aseptic processing areas. This included a calibration weight box, a transport bin, and IV bags being placed directly into ISO 5 hoods without prior sanitization on April 18, 2018. Personnel engaged in aseptic processing were observed with exposed bare hands on April 17 and 18, 2018, prior to or during sterile drug production and hood preparation. These critical findings indicate deficiencies in maintaining aseptic conditions and adherence to sterile compounding protocols.