# FDA 483 - Allegheny Health Network Home Infusion, LLC - September 25, 2018

Source: https://www.keypedia.com/records/483/allegheny-health-network-home-infusion-llc/aebf14ac-73e9-45b0-8fb3-c316e4d13d78

> FDA 483 for Allegheny Health Network Home Infusion, LLC on September 25, 2018. 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: 2018-09-25
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: This FDA Form 483 was issued to Allegheny Health Network Home Infusion, LLC, a producer of sterile drugs located at 311 23rd St., Ext., Ste. 500, Sharpsburg, PA 15215. The inspection occurred from September 17-21, 2018, with the 483 issued on September 25, 2018, to Monica A. Lane, Pharmacy Manager.

Two observations were noted:
1.  Personnel donned gowning apparel improperly, potentially causing contamination. Specifically, on September 20, 2018, an operator was observed donning a used disposable coverall, allowing the coverall's legs to contact the Ante Room floor.
2.  Disinfecting agents and cleaning pads or wipes used in the ISO 5 aseptic processing area were not sterile. On September 17, 2018, non-sterile lint-free wipes were applied to surfaces within the ISO 5 area of the workbench in the non-hazard clean room, where sterile products like Milrinone 0.8mg/ml and Methylprednisolone 1g/100ml were produced.

## 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 - 2014-12-05](https://www.keypedia.com/records/483/allegheny-health-network-home-infusion-llc/0f675b1c-0151-49a1-8608-4b319733b20d)

## Related Officers

- [Supervisory Consumer Safety Officer, China Office](https://www.keypedia.com/people/marcus-a-ray/d394d757-5569-4697-bec1-c24113e29d6f)

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