FDA 483 - alexander infusion llc - August 01, 2016

This FDA Form 483 details observations from an inspection, highlighting multiple deficiencies in aseptic processing and quality control.

**Facility and Operations:** The inspection concerns a facility producing sterile preparations, including drug products processed in ISO 7 clean rooms and ISO 5 laminar flow hoods.

**Violations and Observations:**

1. **Aseptic Processing Area Control:** Smoke studies are deficient, not conducted under dynamic conditions or mimicking challenging preparations to verify unidirectional airflow in ISO 7 and ISO 5 areas. 2. **Stability Testing:** No written stability program exists to support expiration dates for sterile preparations, and potency testing has never been performed. 3. **Personnel Gowning:** Non-sterile gowns are used for sterile preparations. An operator was observed with exposed head, facial skin, shoulders, and arms in an ISO 5 hood while wearing non-sterile attire. Sterile sleeves are still lacking for gowns in the (b)(4) Room, a repeat deficiency. 4. **Environmental Monitoring:** * Personnel fingertip sampling is not conducted at least daily during operations. * Viable air counts in ISO 5 areas are not performed daily during production. * Work surfaces inside ISO 5 hoods are not tested for microbial contamination daily during and at the end of operations. 5. **Sterility Testing:** * Sterility testing uses a (b)(4) with incorrect incubation temperature ((b)(