FDA 483 - Resource Optimization & Innovation LLC - November 29, 2016

The FDA Form 483 details multiple deficiencies at an unnamed outsourcing facility producing sterile drug products, including Phenylephrine.

**Microbiological Contamination Prevention:** * Procedures for preventing microbiological contamination are not established or followed. * Smoke study (unidirectional airflow pattern evaluation) for the ISO 5 Laminar Airflow Workbench (LAFW) was inadequate, specifically regarding settling plate placement for monitoring filling and the complete hood environment. * Volumetric air sampling of the ISO 5 hood is not conducted during compounding operations.

**Environmental Monitoring (EM):** * EM sampling is not performed in all appropriate locations. * Surface sampling in the (b)(4) Room is not performed on all significant objects touched/handled during compounding (e.g., (b)(4) pumps, (b)(4) electronic tablets). * Multiple (b)(4) electronic tablets are used interchangeably without identification to track which have been monitored.

**Batch Production and Control Records:** * Batch records are deficient, lacking correct actual dates and times for compounding operations (e.g., Phenylephrine 100 mg/mL lots 38824, 39124, 39138, 39316). * Untrained personnel (Material Handler) were documented as performing compounding operations in sterile areas (e.g., Phenylephrine 100