Invotec International Inc.
Form 483 issued February 5, 2019 · Jacksonville, Florida
- Inspection
- Feb 4 – Feb 5, 2019
- Investigator
- Lisa A. Warner
- Observations
- 2
- Pages
- 5
- FEI number
- 1000113735
In short: On February 5, 2019, FDA issued a Form 483 with 2 observations to Invotec International Inc. in Jacksonville, Florida (FEI 1000113735) after an inspection that ran Feb 4 – Feb 5, 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
2 of 2 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75(b) (1×) · 820.75(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for monitoring and control of process parameters for a validated process have…
- 02
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 firmInvotec International Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Invotec International Inc.?
FDA listed 2 observations 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 Invotec International Inc.?
Lisa A. Warner is named on this Form 483, for the inspection of Feb 4 – Feb 5, 2019. Each investigator has a profile showing what they cite most.
When was Invotec International Inc. inspected by FDA?
The inspection ran Feb 4 – Feb 5, 2019, and the Form 483 is dated February 5, 2019.
How do I get the full Form 483 for Invotec International 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.