FDA WARNING_LETTER - Park Infusioncare LP dba Preferred Homecare - July 11, 2017

On March 1, 2018, the FDA issued a Warning Letter to Preferred Homecare (Park Infusioncare LP dba Preferred Homecare) following an inspection from June 27 to July 11, 2017, at their Dallas, Texas facility. The inspection revealed serious deficiencies in sterile drug product production, rendering products adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions.

Violations included: dead insects in the pharmacy and aseptic production areas; residue in the ISO 7 cleanroom, including an ISO 5 hood and an (b)(4); use of non-sterile wipes and disinfectant; poor aseptic practices such as an operator returning to aseptic operations without changing or sanitizing gloves after leaving the cleanroom, and improper sterile glove donning; and media fill studies not performed under challenging conditions.

While Preferred Homecare submitted a response to the Form FDA 483, several corrective actions lacked adequate supporting documentation. Specifically, proof of residue removal, replacement of non-sterile items with sterile ones (e.g., purchase orders, COAs), and revised procedures for (b)(4) use with TPN manipulations, along with completed media fill simulations, were not provided.

The FDA strongly recommended a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems, particularly aseptic processing, with assistance from a third-party