Del Medical, Inc
Form 483 issued September 23, 2015 · Bloomingdale, Illinois
- Inspection
- Jul 8 – Sep 23, 2015
- Investigator
- Patricia A. McIlroy
- Observations
- 5
- Pages
- 4
- FEI number
- 1418964
In short: On September 23, 2015, FDA issued a Form 483 with 5 observations to Del Medical, Inc in Bloomingdale, Illinois (FEI 1418964) after an inspection that ran Jul 8 – Sep 23, 2015. The investigator was Patricia A. McIlroy. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
4 of 5 observations on this 483 concern capa.
Most cited: 21 CFR 820.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A correction or removal, conducted to reduce a risk to health posed by a device, was…
- 02
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 03
Corrective and preventive action activities and/or results…
- 04
Procedures for corrective and preventive action have…
This inspection in context
Patricia A. McIlroy
1 document · 2015
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Illinois.
The firmDel Medical, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Del Medical, Inc?
FDA listed 5 observations on this Form 483, mostly about cAPA and design controls. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Del Medical, Inc?
Patricia A. McIlroy is named on this Form 483, for the inspection of Jul 8 – Sep 23, 2015. Each investigator has a profile showing what they cite most.
When was Del Medical, Inc inspected by FDA?
The inspection ran Jul 8 – Sep 23, 2015, and the Form 483 is dated September 23, 2015.
How do I get the full Form 483 for Del Medical, Inc?
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.