Awareness Technology, Inc.
Form 483 issued June 12, 2023 · Palm City, Florida
- Inspection
- Jun 6 – Jun 12, 2023
- Investigator
- Alex J. Wild
- Observations
- 3
- Pages
- 4
- FEI number
- 1036223
In short: On June 12, 2023, FDA issued a Form 483 with 3 observations to Awareness Technology, Inc. in Palm City, Florida (FEI 1036223) after an inspection that ran Jun 6 – Jun 12, 2023. The investigator was Alex J. Wild. Most observations concern cAPA and production & process controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Corrective and preventive action activities and/or results have…
- 02
Records of complaint investigations do…
- 03
Schedules for the adjustment, cleaning, and other maintenance of equipment have…
This inspection in context
Alex J. Wild
4 documents · 2023–2026
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Florida.
The firmAwareness Technology, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Awareness Technology, Inc.?
FDA listed 3 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Awareness Technology, Inc.?
Alex J. Wild is named on this Form 483, for the inspection of Jun 6 – Jun 12, 2023. Each investigator has a profile showing what they cite most.
When was Awareness Technology, Inc. inspected by FDA?
The inspection ran Jun 6 – Jun 12, 2023, and the Form 483 is dated June 12, 2023.
How do I get the full Form 483 for Awareness Technology, 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.