FDA 483 - New Era Pharmacy, LLC - October 04, 2016

The FDA Form 483 details multiple deficiencies in aseptic processing, environmental monitoring, personnel practices, sterilization, and cleaning procedures at a facility producing sterile drug products.

**Environmental Monitoring & Aseptic Processing:** * Smoke study qualification of sterile production suites lacked video and condition descriptions, preventing confirmation. * Initial sterile compounding suite qualification did not include dynamic conditions. * Environmental monitoring (air, surface) and personnel monitoring (microbial) are not performed during sterile production. * SOP No. 9 "Environmental Monitoring/Testing" specifies air sampling "(b)(4)", surface testing "every (b)(4)", and testing "every (b)(4)" to verify USP <797> ISO 8, ISO 7, and ISO 5 air quality, but these are not followed during production.

**Personnel Practices:** * SOP No. 12 "Glove fingertip sampling and gowning documentation" is deficient as it doesn't require operators to roll fingertips side-to-side. * SOP No. 13 "Garbing, Gowning and Gloving Process..." doesn't require sampling of gown areas (forehead, face, shoulder, chest). * SOP No. 10 "Garbing Procedure Technique" is deficient; it doesn't state face/neck should be completely covered or address street clothing exposure in the ISO7 room. *