FDA 483 - OurPharma LLC - September 30, 2021

This FDA Form 483 document outlines deficiencies observed during an inspection of an unnamed facility's aseptic processing areas.

**Environmental Monitoring Deficiencies:** * The firm lacks documented justification for the orientation of non-viable particle monitoring probes within the ISO 5 biological safety cabinets (BSCs). * The isokinetic probe's placement is not fixed and is subject to movement during BSC cleaning, preventing demonstration of meaningful sample collection. * The non-viable particulate probes and active air samplers within the ISO 5 BSCs have not been qualified under actual conditions of use. The initial system qualification occurred in (b)(4), while the BSCs were installed in January/February 2019.

**Cleaning and Disinfection Deficiencies:** * The material used for the armrests on the ISO 5 BSCs was not included in the disinfectant efficacy study, meaning there is no documentation to show disinfectant effectiveness on this specific material. * The firm has not evaluated the suitability of the armrest material for use in an ISO 5/ISO 7 cleanroom environment or for sterile production.