Septodont Inc.
FDA inspection history in Louisville, Colorado, 2018 to 2019
- 2
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19Two Form 483s, at Louisville, Colorado.
- 2019The longest 483 on file: 3 observations over 6 pages at Louisville, Colorado.
Cited most
Across all Septodont observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
The complete Septodont file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Louisville, Colorado
Two Form 483s · 2018 to 2019 · 4 observations
Latest: Form 483, Aug 12, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-08-12 | 483 Form 483 | Louisville, Colorado | 3 | $99 |
| 2018-12-21 | 483 Form 483 | Louisville, Colorado | 1 | $99 |
Investigators on these documents
FEI number 1721729 · most recent document Aug 12, 2019
About Septodont Inc.
How many FDA Form 483s has Septodont Inc. received?
FDA Intel has 2 Form 483s on file for Septodont Inc.; the most recent is dated Aug 12, 2019.
When was Septodont Inc. last inspected by FDA?
The most recent FDA inspection document on file for Septodont Inc. is a Form 483 dated Aug 12, 2019, for the site in Louisville, Colorado.
What did FDA cite at Septodont Inc.?
The regulations cited most in the observations on file for Septodont Inc. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.160 (General requirements), 1 time.