Atlantic Analytical Laboratories LLC 291 UU Highway 22 East, Buiding 1 & 2
Form 483 issued March 17, 2026 · Whitehouse, New Jersey
- Inspection
- Mar 2 – Mar 17, 2026
- Investigator
- Jessica S. Estriplet
- Observations
- 1
- Pages
- 3
- FEI number
- 2246907
In short: On March 17, 2026, FDA issued a Form 483 with 1 observation to Atlantic Analytical Laboratories LLC 291 UU Highway 22 East, Buiding 1 & 2 in Whitehouse, New Jersey (FEI 2246907) after an inspection that ran Mar 2 – Mar 17, 2026. The investigator was Jessica S. Estriplet. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194(a)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The suitability of all testing methods is not verified under…
This inspection in context
Jessica S. Estriplet
18 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmAtlantic Analytical Laboratories LLC 291 UU Highway 22 East, Buiding 1 & 2 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194(a)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Atlantic Analytical Laboratories LLC 291 UU Highway 22 East, Buiding 1 & 2?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Atlantic Analytical Laboratories LLC 291 UU Highway 22 East, Buiding 1 & 2?
Jessica S. Estriplet is named on this Form 483, for the inspection of Mar 2 – Mar 17, 2026. Each investigator has a profile showing what they cite most.
When was Atlantic Analytical Laboratories LLC 291 UU Highway 22 East, Buiding 1 & 2 inspected by FDA?
The inspection ran Mar 2 – Mar 17, 2026, and the Form 483 is dated March 17, 2026.
How do I get the full Form 483 for Atlantic Analytical Laboratories LLC 291 UU Highway 22 East, Buiding 1 & 2?
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.