Triangle Manufacturing Co. Inc
Form 483 issued June 12, 2025 · Upper Saddle River, New Jersey
- Inspection
- May 20 – Jun 12, 2025
- Investigator
- Matthew W. Kyle
- Observations
- 2
- Pages
- 5
- FEI number
- 1000491390
In short: On June 12, 2025, FDA issued a Form 483 with 2 observations to Triangle Manufacturing Co. Inc in Upper Saddle River, New Jersey (FEI 1000491390) after an inspection that ran May 20 – Jun 12, 2025. The investigator was Matthew W. Kyle. Most observations concern production & process controls and management controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
Production & process controls and management controls account for 2 of 2 observations.
Most cited: 21 CFR 820.75(a) (1×) · 820.25(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for training and identifying training needs have…
This inspection in context
Matthew W. Kyle
3 documents · 2023–2025
Cites 820.25(b) (personnel) more than any other section. Most of their documents are for sites in New Jersey.
The firmTriangle Manufacturing Co. Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Triangle Manufacturing Co. Inc?
FDA listed 2 observations on this Form 483, mostly about production & process controls and management controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Triangle Manufacturing Co. Inc?
Matthew W. Kyle is named on this Form 483, for the inspection of May 20 – Jun 12, 2025. Each investigator has a profile showing what they cite most.
When was Triangle Manufacturing Co. Inc inspected by FDA?
The inspection ran May 20 – Jun 12, 2025, and the Form 483 is dated June 12, 2025.
How do I get the full Form 483 for Triangle Manufacturing Co. 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.