Active Intelligence, LLC
Form 483 issued March 8, 2024 · Cherryville, North Carolina
- Inspection
- Mar 5 – Mar 8, 2024
- Investigator
- Harshal J. Desai
- Observations
- 4
- Pages
- 4
- FEI number
- 3014556381
In short: On March 8, 2024, FDA issued a Form 483 with 4 observations to Active Intelligence, LLC in Cherryville, North Carolina (FEI 3014556381) after an inspection that ran Mar 5 – Mar 8, 2024. The investigator was Harshal J. Desai. Most observations concern laboratory controls and quality system.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
There is no written testing program designed to assess the stability…
- 02
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
- 03
Access to the storage area for labels and labeling materials is not…
- 04
There was a failure to handle and store components and drug product containers at all times…
This inspection in context
Harshal J. Desai
6 documents · 2022–2024
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in Florida.
The firmActive Intelligence, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Active Intelligence, LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Active Intelligence, LLC?
Harshal J. Desai is named on this Form 483, for the inspection of Mar 5 – Mar 8, 2024. Each investigator has a profile showing what they cite most.
When was Active Intelligence, LLC inspected by FDA?
The inspection ran Mar 5 – Mar 8, 2024, and the Form 483 is dated March 8, 2024.
How do I get the full Form 483 for Active Intelligence, 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.