Custom Analytics LLC
Form 483 issued March 12, 2026 · Dalzell, South Carolina
- Inspection
- Mar 9 – Mar 12, 2026
- Investigator
- J'maica J. Hunter
- Observations
- 3
- Pages
- 4
- FEI number
- 3003261962
In short: On March 12, 2026, FDA issued a Form 483 with 3 observations to Custom Analytics LLC in Dalzell, South Carolina (FEI 3003261962) after an inspection that ran Mar 9 – Mar 12, 2026. The investigator was J'maica J. Hunter. Most observations concern facilities & equipment and quality system.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
The separate or defined areas necessary to prevent contamination…
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
J'maica J. Hunter
5 documents · 2024–2026
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Georgia.
The firmCustom Analytics LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Custom Analytics LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Custom Analytics LLC?
J'maica J. Hunter is named on this Form 483, for the inspection of Mar 9 – Mar 12, 2026. Each investigator has a profile showing what they cite most.
When was Custom Analytics LLC inspected by FDA?
The inspection ran Mar 9 – Mar 12, 2026, and the Form 483 is dated March 12, 2026.
How do I get the full Form 483 for Custom Analytics 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.