Northern Digital Inc.
Form 483 issued August 28, 2025
- Inspection
- Aug 25 – Aug 28, 2025
- Investigator
- Felix J. Marrero
- Observations
- 4
- Pages
- 5
- FEI number
- 3002743211
In short: On August 28, 2025, FDA issued a Form 483 with 4 observations to Northern Digital Inc. (FEI 3002743211) after an inspection that ran Aug 25 – Aug 28, 2025. The investigator was Felix J. Marrero. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
CAPA and production & process controls account for 3 of 4 observations.
Most cited: 21 CFR 803 (3×)
What FDA observed
Preview: the opening words of each observation- 0121 CFR 803
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 0221 CFR 803
Written MDR procedures have…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 0421 CFR 80321 CFR 80721 CFR 820
Personnel do not have the necessary background, training and experience…
This inspection in context
Felix J. Marrero
7 documents · 2011–2025
Cites 803 more than any other section. Most of their documents are for sites in Colorado.
The firmNorthern Digital Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Northern Digital Inc.?
FDA listed 4 observations on this Form 483, mostly about cAPA, production & process controls and management controls. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected Northern Digital Inc.?
Felix J. Marrero is named on this Form 483, for the inspection of Aug 25 – Aug 28, 2025. Each investigator has a profile showing what they cite most.
When was Northern Digital Inc. inspected by FDA?
The inspection ran Aug 25 – Aug 28, 2025, and the Form 483 is dated August 28, 2025.
How do I get the full Form 483 for Northern Digital 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.