Septodont Inc.
Form 483 issued December 21, 2018 · Louisville, Colorado
- Investigator
- Jamie L. Dion
- Observations
- 1
- Pages
- 2
- FEI number
- 1721729
In short: On December 21, 2018, FDA issued a Form 483 with 1 observation to Septodont Inc. in Louisville, Colorado (FEI 1721729). The investigator was Jamie L. Dion. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Jamie L. Dion
11 documents · 2013–2019
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Colorado.
The firmSeptodont Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Septodont Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Septodont Inc.?
Jamie L. Dion is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Septodont Inc. inspected by FDA?
This Form 483 is dated December 21, 2018.
How do I get the full Form 483 for Septodont 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.