Easy Healthcare Corporation
Form 483 issued August 24, 2018 · Burr Ridge, Illinois
- Inspection
- Aug 21 – Aug 24, 2018
- Investigator
- Emma R. Schaefer
- Observations
- 2
- Pages
- 5
- FEI number
- 3012725363
In short: On August 24, 2018, FDA issued a Form 483 with 2 observations to Easy Healthcare Corporation in Burr Ridge, Illinois (FEI 3012725363) after an inspection that ran Aug 21 – Aug 24, 2018. The investigator was Emma R. Schaefer. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
2 of 2 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.50(a)(2) (1×) · 820.50(a)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The type and extent of control to be exercised over the product…
- 02
Potential suppliers were not selected based on their ability…
This inspection in context
Emma R. Schaefer
4 documents · 2018–2021
Cites 820.50 (purchasing controls) more than any other section. Most of their documents are for sites in Illinois.
The firmEasy Healthcare Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.50(a)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Easy Healthcare Corporation?
FDA listed 2 observations on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected Easy Healthcare Corporation?
Emma R. Schaefer is named on this Form 483, for the inspection of Aug 21 – Aug 24, 2018. Each investigator has a profile showing what they cite most.
When was Easy Healthcare Corporation inspected by FDA?
The inspection ran Aug 21 – Aug 24, 2018, and the Form 483 is dated August 24, 2018.
How do I get the full Form 483 for Easy Healthcare Corporation?
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.