FDA 483 - Accurate RX Pharmacy Consulting LLC - September 19, 2018

The FDA Form 483 documents observations from an inspection of a facility producing human sterile drug products with Beyond Use Dates greater than 12 hours. The primary aseptic processing area, an ISO 5 classified (b) (4) , (b) (4) , is located within a non-classified room.

Several critical deficiencies were noted: 1. **Environmental Control:** The ISO 5 (b) (4) , (b) (4) , is (b) (4) in the open position during cleaning and (b) (4) certification, exposing both ISO 5 chambers (ante & main) to unclassified air. This was observed on 9/11/2018 and 9/13/2018. 2. **Personnel Gowning:** Technicians do not don sterile gowning garb when performing operations inside the ISO 5 (b) (4) during cleaning and (b) (4) certification. This was observed on 9/11/2018 and 9/13/2018. 3. **Pressure Differential:** The ISO 5 (b) (4) , (b) (4) , does not consistently maintain a positive pressure differential (>0.02” wc) between the main chamber and the ante chamber during material transfers. On 9/11/2018 and 9/