Particle Dynamics
Form 483 issued April 14, 2025 · Seymour, Indiana
- Inspection
- Apr 8 – Apr 14, 2025
- Investigator
- Muna Algharibeh
- Observations
- 1
- Pages
- 2
- FEI number
- 3002864625
In short: On April 14, 2025, FDA issued a Form 483 with 1 observation to Particle Dynamics in Seymour, Indiana (FEI 3002864625) after an inspection that ran Apr 8 – Apr 14, 2025. The investigator was Muna Algharibeh. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.65 (equipment construction).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.65 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to ensure that equipment surfaces in contact with intermediates and active pharmaceutical ingredients (APIs) do…
This inspection in context
Muna Algharibeh
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Indiana.
The firmParticle Dynamics history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.65
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Particle Dynamics?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.65 (equipment construction). The opening words of each observation are shown on this page.
Who inspected Particle Dynamics?
Muna Algharibeh is named on this Form 483, for the inspection of Apr 8 – Apr 14, 2025. Each investigator has a profile showing what they cite most.
When was Particle Dynamics inspected by FDA?
The inspection ran Apr 8 – Apr 14, 2025, and the Form 483 is dated April 14, 2025.
How do I get the full Form 483 for Particle Dynamics?
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.