# FDA 483 - Allegheny Health Network Home Infusion, LLC - December 05, 2014

Source: https://www.keypedia.com/records/483/allegheny-health-network-home-infusion-llc/0f675b1c-0151-49a1-8608-4b319733b20d

> FDA 483 for Allegheny Health Network Home Infusion, LLC on December 05, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allegheny Health Network Home Infusion, LLC
- Inspection Date: 2014-12-05
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: During an FDA inspection, multiple deficiencies were observed in the compounding and aseptic processing of sterile injectable products.

**Facility and Operations:**
*   Production of Total Parenteral Nutrition (TPN) was observed in an ISO 6 Compounding Room instead of ISO 5 conditions, with opened ampoules exposed.
*   Components were staged in a manner requiring technicians to extend over opened ampoules.
*   The TPN workbench and Chemo Biological Safety Cabinet lacked proper ISO 5 qualification through airflow studies (smoke studies) under static and dynamic conditions.
*   Technicians moved freely in the ISO 6 area without restriction, and the demarcation between ISO 5 and ISO 6 was unclear.

**Violations and Quality System Issues:**
*   **Aseptic Technique Deficiencies:**
    *   Vigorous shaking of product after diluent addition was observed.
    *   Frequent contact with non-sterile components/surfaces (door handle, trash bag, scissors, packaging) without sanitizing gloved hands with sterile 70% isopropyl alcohol.
    *   Reusing a single sanitizing sterile pad multiple times on opened vials and sterile connections, even after rewetting.
    *   Applying non-sterile hand rub to sterile gloves.
    *   Immediately wiping gloved hands with non-sterile wipes after sanitizing, not allowing sufficient contact time for isopropyl alcohol.
    *   Picking up trash from the floor and immediately resuming

## Related Documents

- [483_RESPONSE - 2014-09-19](https://www.keypedia.com/records/483_response/allegheny-health-network-home-infusion-llc/93b6abee-2e8f-4ca7-b9f2-8cfe1355443f)
- [483_RESPONSE - 2014-12-05](https://www.keypedia.com/records/483_response/allegheny-health-network-home-infusion-llc/b000e445-6eb2-4cfd-b1f4-e37b3ec24cc3)
- [483 - 2018-09-25](https://www.keypedia.com/records/483/allegheny-health-network-home-infusion-llc/aebf14ac-73e9-45b0-8fb3-c316e4d13d78)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/thomas-e-friel/205f23ee-8648-46d1-8485-11977a27e8e4)
- [Consumer Safety Officer](https://www.keypedia.com/people/dorcas-a-taylor/7c5bef37-3f82-4470-976c-dfa3e90d1d88)

Company: https://www.keypedia.com/companies/allegheny-health-network-home-infusion-llc/2971c33c-0c78-48b0-879a-b9c2af88dfc5

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