Gateway Analytical, LLC
Form 483 issued March 20, 2026 · Gibsonia, Pennsylvania
- Inspection
- Mar 18 – Mar 20, 2026
- Investigator
- Kara J. Wright
- Observations
- 1
- Pages
- 2
- FEI number
- 3009255642
In short: On March 20, 2026, FDA issued a Form 483 with 1 observation to Gateway Analytical, LLC in Gibsonia, Pennsylvania (FEI 3009255642) after an inspection that ran Mar 18 – Mar 20, 2026. The investigator was Kara J. Wright. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Kara J. Wright
9 documents · 2024–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.
The firmGateway Analytical, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gateway Analytical, LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Gateway Analytical, LLC?
Kara J. Wright is named on this Form 483, for the inspection of Mar 18 – Mar 20, 2026. Each investigator has a profile showing what they cite most.
When was Gateway Analytical, LLC inspected by FDA?
The inspection ran Mar 18 – Mar 20, 2026, and the Form 483 is dated March 20, 2026.
How do I get the full Form 483 for Gateway Analytical, 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.