Alfred I. duPont Hospital for Children
Form 483 issued June 29, 2016 · Wilmington, Delaware
- Inspection
- Jun 29, 2016
- Investigator
- Thomas E. Friel
- Observations
- 5
- Pages
- 4
- FEI number
- 2570172
In short: On June 29, 2016, FDA issued a Form 483 with 5 observations to Alfred I. duPont Hospital for Children in Wilmington, Delaware (FEI 2570172) after an inspection that ran Jun 29, 2016. The investigator was Thomas E. Friel. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Thomas E. Friel
13 documents · 2013–2017
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAlfred I. duPont Hospital for Children history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alfred I. duPont Hospital for Children?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Alfred I. duPont Hospital for Children?
Thomas E. Friel is named on this Form 483, for the inspection of Jun 29, 2016. Each investigator has a profile showing what they cite most.
When was Alfred I. duPont Hospital for Children inspected by FDA?
The inspection ran Jun 29, 2016, and the Form 483 is dated June 29, 2016.
How do I get the full Form 483 for Alfred I. duPont Hospital for Children?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.