FDA WARNING_LETTER - Option Care - June 28, 2016

On July 20, 2017, the FDA issued a Warning Letter to Option Care Enterprises, Inc. dba Option Care, following an inspection from June 20-28, 2016, at their Columbia, MD facility. The inspection revealed serious deficiencies in sterile drug product production, leading to adulterated drug products under section 501(a)(2)(A) of the FDCA.

Violations included insanitary conditions: using non-sterile wipes and disinfectant in aseptic areas, observed rust and residue on an ISO 5 hood grill, a technician contaminating gloves/gown by reaching into a trash container and continuing work without sanitization, and materials brought into the ISO 5 hood without prior disinfection. Additionally, media fills did not adequately simulate aseptic operations, including worst-case activities.

Option Care's July 20, 2016, response to the FDA-483 was partially inadequate. The firm incorrectly stated that sterile wipes and disinfectants are not required by state regulations or USP <797>, which the FDA refutes as increasing contamination risk. Some proposed corrective actions lacked supporting documentation, such as cleaning the ISO 5 hood and changing aseptic validation kits.

The FDA strongly recommended a comprehensive assessment of operations, particularly aseptic processing, with assistance from a third-party consultant. Failure to promptly correct violations may result in legal action. Option Care must respond within fifteen working days, detailing corrective actions