4FRONT Solutions, LLC
Form 483 issued June 12, 2019 · Deland, Florida
- Inspection
- Jun 6 – Jun 12, 2019
- Investigator
- Lisa A. Warner
- Observations
- 1
- Pages
- 9
- FEI number
- 3013484065
In short: On June 12, 2019, FDA issued a Form 483 with 1 observation to 4FRONT Solutions, LLC in Deland, Florida (FEI 3013484065) after an inspection that ran Jun 6 – Jun 12, 2019. The investigator was Lisa A. Warner. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Lisa A. Warner
6 documents · 2011–2019
Cites 820.75 (process validation) more than any other section. Most of their documents are for sites in Florida.
The firm4FRONT Solutions, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at 4FRONT Solutions, LLC?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected 4FRONT Solutions, LLC?
Lisa A. Warner is named on this Form 483, for the inspection of Jun 6 – Jun 12, 2019. Each investigator has a profile showing what they cite most.
When was 4FRONT Solutions, LLC inspected by FDA?
The inspection ran Jun 6 – Jun 12, 2019, and the Form 483 is dated June 12, 2019.
How do I get the full Form 483 for 4FRONT Solutions, LLC?
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.