FDA 483 - Delta Pharma, Inc. - May 20, 2022

The FDA Form 483 details observations from an inspection, highlighting deficiencies in the facility's aseptic processing of drug products.

**Personnel Gowning and Contamination Control:** The firm's gowning location is inadequate, with face masks, head/beard covers, gloves, shoe covers, and gowns donned in a non-classified hallway before entering controlled areas (corridor, Room 3 (anteroom), and Room 2 (ISO 8)). The same shoe covers are worn in Room 3 and Room 2. Dedicated scrubs, worn in multiple areas including classified rooms and non-classified areas, are also a concern. This is a repeat observation from inspections in 2013, 2016, and 2017.

**Cleaning and Disinfection:** The stated contact disinfectant time for (b)(4) (10 minutes) conflicts with the manufacturer's recommended sporicidal contact time of 30 minutes, despite aligning with an internal cleaning efficacy study.

**Aseptic Processing Area Deficiencies:** During a media fill run on May 18, 2022, a bag of sterile rubber stoppers was improperly oriented in the ISO-5 laminar hood, with the opened end not exposed to first-pass air.

**Equipment Calibration and Monitoring:** Routine calibration of the automated (b)(4) is deficient. A media fill run on May 16, 2022, showed