Danmar Products, Inc
Form 483 issued November 4, 2024 · Ann Arbor, Michigan
- Inspection
- Oct 22 – Nov 4, 2024
- Investigator
- Felicia E. Armbrustmacher
- Observations
- 7
- Pages
- 8
- FEI number
- 1831680
In short: On November 4, 2024, FDA issued a Form 483 with 7 observations to Danmar Products, Inc in Ann Arbor, Michigan (FEI 1831680) after an inspection that ran Oct 22 – Nov 4, 2024. The investigator was Felicia E. Armbrustmacher. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Process validation results have…
- 02
Procedures for collective and preventive action have…
- 03
Procedures to ensure equipment is routinely calibrated, checked and maintained have…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Felicia E. Armbrustmacher
1 document · 2024
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Michigan.
The firmDanmar Products, 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 Danmar Products, Inc?
FDA listed 7 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Danmar Products, Inc?
Felicia E. Armbrustmacher is named on this Form 483, for the inspection of Oct 22 – Nov 4, 2024. Each investigator has a profile showing what they cite most.
When was Danmar Products, Inc inspected by FDA?
The inspection ran Oct 22 – Nov 4, 2024, and the Form 483 is dated November 4, 2024.
How do I get the full Form 483 for Danmar Products, 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.