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

Source: https://www.keypedia.com/records/483/nemours-alfred-i-dupont-hospital-for-children/62dd2afc-d44d-455a-af2a-ca3e63526581

> FDA 483 for Nemours Alfred I. duPont Hospital for Children on June 29, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nemours Alfred I. duPont Hospital for Children
- Inspection Date: 2016-06-29
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: 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

## Related Documents

- [STATE_REFERRAL_LETTER - 2016-06-25](https://www.keypedia.com/records/state_referral_letter/nemours-alfred-i-dupont-hospital-for-children/48ddfcfa-a892-4a6f-b48c-07782a80b358)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/thomas-e-friel/205f23ee-8648-46d1-8485-11977a27e8e4)

Company: https://www.keypedia.com/companies/nemours-alfred-i-dupont-hospital-for-children/fefd4e17-c707-48c1-9d64-984f34ee8fb1

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8