FDA 483 - Preferred Homecare (Park Infusioncare LP) - February 17, 2017

An FDA inspection conducted on February 13, 14, and 17, 2017, at Park Infusioncare, LP dba Preferred Homecare, an aseptic drug processor in Houston, TX, resulted in a Form FDA 483 detailing significant observations. The primary concerns revolved around the facility's design, maintenance, and environmental controls, crucial for maintaining sterile conditions. Inspectors observed multiple structural and maintenance deficiencies. These included wooden, visibly damaged, or discolored surfaces in ISO 5 hoods and the ISO 7 anteroom that were not amenable to proper cleaning. Gaps were noted between HEPA filters and ceilings, some taped, and displaced ceiling tiles exposed classified areas to unclassified spaces. Rust, cracks, and dust accumulation were also present in critical areas. Furthermore, the firm failed to adequately monitor air quality. Pressure differentials between classified and unclassified areas were not actively monitored or recorded, and gauges were uncalibrated. This led to negative pressure in the anteroom relative to the cleanroom during several months in 2016 while aseptic processing continued, without accurate readings to identify the problem earlier. Room certification processes were also found deficient, lacking dynamic smoke studies and HEPA integrity assessments, with a technician even stating rooms were not designed to pass smoke tests. Lastly, the firm's cleaning protocols were inadequate, as sporicidal agents were not used in ISO 5 hoods. These observations indicate a failure to maintain a controlled environment for sterile drug manufacturing, necessitating prompt corrective actions from the company.