FDA WARNING_LETTER - Option Care Enterprises, Inc. dba Option Care - April 28, 2016

An FDA inspection of Baptist Health Medical Towers Pharmacy and Infusion Services from April 11-28, 2016, revealed serious deficiencies in sterile drug product production, posing patient risks. A subsequent joint investigation with the Arkansas State Board of Pharmacy occurred on February 28, 2017.

The facility's drug products were deemed adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions. Observed violations included: black spots on HEPA filters in the ISO 7 buffer room, a white substance on metal diffusers in an ISO 5 hood, and rust-colored spots on HEPA filters in two ISO 5 hoods. Poor aseptic practices were noted, such as a technician touching sterile glove exteriors with bare hands and failing to disinfect sterile gloves or materials before introducing them into the ISO 5 area. Non-sterile disinfectants were used in aseptic processing areas. These acts constitute a prohibited act under section 301(k) of the FDCA.

The FDA acknowledged the firm's May 13, 2016, response to the FDA 483, the April 18, 2016, voluntary recall of all in-expiry sterile products produced from April 6-15, 2016, due to lack of sterility assurance, and the April 20, 2016, consent