FDA 483 - Advanced Infusion Solutions - January 30, 2023

This FDA Form 483 documents observations from an inspection of a facility producing sterile intrathecal injectable drug products.

**Violations and Observations:**

1. **Non-depyrogenated tools:** The firm used sterile (b)(4) syringes during aseptic production without assurance of them being endotoxin/pyrogen-free. An example cited was Lot (b)(4), used on (b)(4) but tested for endotoxin on (b)(4). This indicates a lack of pre-use endotoxin/pyrogen verification for critical tools in sterile drug production.

2. **Inadequate product evaluation and remedial action for particle counts:** Actionable particle counts were found in the ISO 5 classified aseptic processing area (ISO5 integrated (b)(4) laminar flow hood) on July 20, 2022, during aseptic production. The firm failed to conduct remedial action or assess the impact on products produced that day. This highlights a deficiency in responding to environmental monitoring excursions and evaluating potential product impact.

3. **Poor cleaning practices in ISO 5 classified areas:** Routine cleaning practices were observed as inadequate. On January 19, 2023, sterile technicians failed to properly disinfect and fully wipe down the underside of (b)(4) located in the ISO 5 hoods used to suspend stock solutions during aseptic production. This indicates a failure to maintain the required cleanliness standards in critical sterile processing environments.

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