Nikao, Inc
Form 483 issued February 18, 2022 · Weston, Florida
- Inspection
- Feb 15 – Feb 18, 2022
- Investigators
- Brandon P. Thompson· Karen M. Rodriguez
- Observations
- 6
- Pages
- 9
- FEI number
- 3005687068
In short: On February 18, 2022, FDA issued a Form 483 with 6 observations to Nikao, Inc in Weston, Florida (FEI 3005687068) after an inspection that ran Feb 15 – Feb 18, 2022. The investigators were Brandon P. Thompson and Karen M. Rodriguez. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Procedures for corrective and preventive action have…
- 03
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 04
Procedures for design change have…
This inspection in context
Brandon P. Thompson
3 documents · 2022–2025
Cites 820.20(b) (management responsibility) more than any other section. Most of their documents are for sites in Florida.
The firmNikao, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nikao, Inc?
FDA listed 6 observations on this Form 483, mostly about cAPA, production & process controls and design controls. The opening words of each observation are shown on this page.
Who inspected Nikao, Inc?
Brandon P. Thompson and Karen M. Rodriguez are named on this Form 483, for the inspection of Feb 15 – Feb 18, 2022. Each investigator has a profile showing what they cite most.
When was Nikao, Inc inspected by FDA?
The inspection ran Feb 15 – Feb 18, 2022, and the Form 483 is dated February 18, 2022.
How do I get the full Form 483 for Nikao, 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.