FDA 483 - Nemours Alfred I. duPont Hospital for Children - June 29, 2016

This FDA Form 483 documents observations from an inspection of a facility engaged in aseptic processing of drug products. The inspection revealed several deficiencies related to maintaining aseptic conditions, preventing microbiological contamination, environmental monitoring, cleaning and disinfection, and personnel gowning.

**Facility and Operations:** The facility utilizes an ISO 8 Ante Room for gowning and an ISO 7 Clean Room leading to an ISO 5 Hood for aseptic processing.

**Violations and Observations:**

1. **Aseptic Processing Area Design and Maintenance (21 CFR 211.42(c)(10)(iv)):** * **ISO 8 Ante Room:** * Personnel movement allowed gowned technicians to interact with un-gowned personnel before entering the Clean Room. * The room has porous, unsealed, and non-cleanable ceiling tiles. * **ISO 7 Clean Room Door:** Partially constructed of wood, which is not readily cleanable. * **Smoke Studies:** No evidence of dynamic smoke studies; vendor-conducted studies did not mimic actual processing conditions, and technicians were not present to simulate processing.

2. **Prevention of Microbiological Contamination (21 CFR 211.113(b)):** * Technicians introduced non-sterile components into the ISO 5 Hood without disinfection. * Technicians frequently exited the ISO