Marson Medical, Inc.
Form 483 issued January 16, 2026 · New Jersey
- Inspection
- Dec 16, 2025 – Jan 16, 2026
- Investigator
- Colin E. Tack
- Observations
- 11
- Pages
- 15
- FEI number
- 1000550978
In short: On January 16, 2026, FDA issued a Form 483 with 11 observations to Marson Medical, Inc. in New Jersey (FEI 1000550978) after an inspection that ran Dec 16, 2025 – Jan 16, 2026. The investigator was Colin E. Tack. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
Production & process controls and capa account for 7 of 11 observations.
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 have not been adequately established to control product that does not…
- 03
Procedures for monitoring and control of process parameters for a validated process have…
- 04
Procedures for device history records…
This inspection in context
Colin E. Tack
8 documents · 2019–2026
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmMarson Medical, 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 Marson Medical, Inc.?
FDA listed 11 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Marson Medical, Inc.?
Colin E. Tack is named on this Form 483, for the inspection of Dec 16, 2025 – Jan 16, 2026. Each investigator has a profile showing what they cite most.
When was Marson Medical, Inc. inspected by FDA?
The inspection ran Dec 16, 2025 – Jan 16, 2026, and the Form 483 is dated January 16, 2026.
How do I get the full Form 483 for Marson Medical, 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.