FDA 483 - Option Care Enterprises, Inc. - February 25, 2016

The FDA Form 483 details significant deficiencies in aseptic processing and quality control for sterile injectable drug products.

**Environmental Monitoring and Investigation:** * The firm's environmental monitoring system is deficient. Positive environmental microbiological results, specifically gram-negative rods like *Acinetobacter baumannii* (ISO 5, June 16, 2015) and *Brevundimonas intermedia* (ISO 8, December 15, 2015), were not investigated for their impact on sterile products, contrary to SOP P-165. * SOP P-165 lacks scientific rationale for environmental monitoring testing frequency. * Surface and active air sampling in ISO 5 hoods are not performed daily during sterile drug production, instead conducted (b)(4). Personnel monitoring is also not daily, and the last technician monitoring was on (b)(4).

**Aseptic Processing and Cleanroom Practices:** * In situ air pattern analysis (smoke studies) from (b)(4) were not conducted under dynamic conditions, failing to simulate routine filling activities with operators and interventions (e.g., set-up, multiple operators). Documentation of smoke study review and adequacy is absent. * Inadequate aseptic techniques were observed on February 9, 2016: * Technician (b)(4) touched non-sterile items and moved in/out of the