Septodont Inc.
Form 483 issued August 12, 2019 · Louisville, Colorado
- Inspection
- Aug 5 – Aug 12, 2019
- Investigators
- Jamie L. Dion· Zachary L. Stamm
- Observations
- 3
- Pages
- 6
- FEI number
- 1721729
In short: On August 12, 2019, FDA issued a Form 483 with 3 observations to Septodont Inc. in Louisville, Colorado (FEI 1721729) after an inspection that ran Aug 5 – Aug 12, 2019. The investigators were Jamie L. Dion and Zachary L. Stamm. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
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 and the failure of a batch or any of…
- 02
Established laboratory control mechanisms are not followed and documented at…
- 03
Written production and process control procedures are not followed in the execution of production and process…
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 3 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Septodont Inc.?
Jamie L. Dion and Zachary L. Stamm are named on this Form 483, for the inspection of Aug 5 – Aug 12, 2019. Each investigator has a profile showing what they cite most.
When was Septodont Inc. inspected by FDA?
The inspection ran Aug 5 – Aug 12, 2019, and the Form 483 is dated August 12, 2019.
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.