NORDSON MEDICAL DESIGN AND DEVELOPMENT, INC.
Form 483 issued October 31, 2023 · San Jose, California
- Inspection
- Oct 25 – Oct 31, 2023
- Investigator
- Christopher R. Czajka
- Observations
- 2
- Pages
- 4
- FEI number
- 3017033740
In short: On October 31, 2023, FDA issued a Form 483 with 2 observations to NORDSON MEDICAL DESIGN AND DEVELOPMENT, INC. in San Jose, California (FEI 3017033740) after an inspection that ran Oct 25 – Oct 31, 2023. The investigator was Christopher R. Czajka. 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 (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
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmNORDSON MEDICAL DESIGN AND DEVELOPMENT, INC. 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 NORDSON MEDICAL DESIGN AND DEVELOPMENT, INC.?
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 NORDSON MEDICAL DESIGN AND DEVELOPMENT, INC.?
Christopher R. Czajka is named on this Form 483, for the inspection of Oct 25 – Oct 31, 2023. Each investigator has a profile showing what they cite most.
When was NORDSON MEDICAL DESIGN AND DEVELOPMENT, INC. inspected by FDA?
The inspection ran Oct 25 – Oct 31, 2023, and the Form 483 is dated October 31, 2023.
How do I get the full Form 483 for NORDSON MEDICAL DESIGN AND DEVELOPMENT, 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.