Morgan Newton Comp
Form 483 issued May 29, 2025 · Plano, Texas
- Inspection
- May 27 – May 29, 2025
- Investigators
- Roy Baby· Yuliana Hernandez-Magana
- Observations
- 2
- Pages
- 4
- FEI number
- 3008312728
In short: On May 29, 2025, FDA issued a Form 483 with 2 observations to Morgan Newton Comp in Plano, Texas (FEI 3008312728) after an inspection that ran May 27 – May 29, 2025. The investigators were Roy Baby and Yuliana Hernandez-Magana. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
2 of 2 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75 (1×) · 820.70(i) (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Software used as part of production has not been validated for its intended use according…
This inspection in context
Roy Baby
3 documents · 2015–2025
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in Texas.
The firmMorgan Newton Comp history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Morgan Newton Comp?
FDA listed 2 observations on this Form 483, mostly about production & process 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 Morgan Newton Comp?
Roy Baby and Yuliana Hernandez-Magana are named on this Form 483, for the inspection of May 27 – May 29, 2025. Each investigator has a profile showing what they cite most.
When was Morgan Newton Comp inspected by FDA?
The inspection ran May 27 – May 29, 2025, and the Form 483 is dated May 29, 2025.
How do I get the full Form 483 for Morgan Newton Comp?
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.