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# FDA Cites duPont Hospital for Pharmacy Compounding
- URL: https://www.fdaweb.com/fda-cites-dupont-hospital-for-pharmacy-compounding/
- Published: 2016-08-08T12:00:00.000Z
- Updated: 2026-09-14T21:22:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136436

FDA has cited Alfred I. duPont Hospital for Children after an inspection of its sterile drug compounding operations found significant GMP violations. A just-posted[ Form 483](http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm514655.pdf?ref=fdaweb.com) said the inspection found that the hospital aseptic processing areas’ systems for maintaining any equipment are deficient. Specifically, it says the hospital’s ISO 8 Ante Room where technicians gown in preparation for aseptic processing is not sufficiently designed because personnel movement in the room allow for gowned technicians to freely interact with un-gowned personnel prior to entering the clean room.

The inspection also found that procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. The 483 said technicians were observed introducing non-sterile components into the ISO 5 hood without disinfecting. And the inspection found that the aseptic processing areas are deficient regarding the system for monitoring environmental conditions. For example, the agency says the frequency of environmental monitoring of surfaces for microbial contamination in the ISO 4 area is inadequate.