HomeChoice Partners, Inc. dba Bioscrip Infusion Services – FDA Warning Letter, Aug 17, 2018

This FDA Warning Letter, dated April 9, 2020, addresses serious deficiencies observed during an inspection of HomeChoice Partners, Inc. dba Bioscrip Infusion Services in Augusta, Georgia, from August 13-17, 2018. The inspection revealed insanitary conditions in the production of sterile drug products, rendering them adulterated under section 501(a)(2)(A) of the FDCA.

Specific violations include: 1. Failure to sanitize tubing between the production of different sterile drug products, risking cross-contamination. 2. Leaving sterile wipes exposed in the ISO 5 area before, during, and after cleaning, risking contamination of the wipes and subsequent spread. 3. Observation of live insects (vermin) in the ante room immediately adjacent to the production area, indicating an environment that may not adequately protect against contamination.

The FDA reviewed the firm's August 29, 2018, response but found it inadequate. Corrective actions regarding pest control and cleaning lacked supporting documentation. The firm's rationale for not sanitizing tubing and for leaving wipes exposed was deemed insufficient. The FDA emphasized that insanitary conditions violate the FDCA regardless of compliance with section 503A.

The letter strongly recommends a comprehensive assessment of operations, particularly aseptic processing, with assistance from a third-party consultant. Failure to promptly correct these violations may result in legal action,