FDA 483 - Imprimis NJOF, LLC - July 10, 2017

The FDA Form 483 document details multiple deficiencies observed during an inspection of a facility manufacturing ophthalmic sterile drug products.

**Environmental Monitoring and Aseptic Processing:** * Aseptic processing areas lacked adequate environmental monitoring for non-viable and viable airborne particles. Specifically, several batches of ophthalmic sterile drug products and their supporting media fills were manufactured, released, and distributed without environmental monitoring, as the (b)(4) and (b)(4) were not operational. * Personnel monitoring was limited to employees' (b)(4) and did not include sleeves, chest, or forehead, despite personnel entering the ISO 5 area during manufacturing. * There was no procedure for using environmental monitoring data to assess and prevent sterility impacts. * Procedures to prevent microbiological contamination lacked adequate validation of the sterilization process. The smoke study for ISO 5 laminar air flow hoods was either not provided or lacked critical activities to demonstrate aseptic conditions.

**Cleaning and Maintenance:** * Written cleaning procedures (EQU-UMR-NJR-007) failed to describe in sufficient detail the techniques and steps for cleaning and disinfecting the ISO 5 laminar air flow hood and various fixtures in the ISO 7 filling room (plastic curtain, doors, lighting).

**Quality Control and Investigations:** * Thorough investigations for customer complaints were not conducted, and corrective actions were not implemented or documented, even for distributed batches. * There were