Discus Dental LLC
FDA inspection history in Ontario, California, 2015 to 2019
- 2
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Ontario, California.
- 2015The longest 483 on file: 10 observations over 7 pages at Ontario, California.
- 2019One Form 483, at Ontario, California.
Cited most
Across all Discus Dental observations on file
- 21 CFR 211.160(a)General requirements3
- 21 CFR 211.192Production record review2
- 21 CFR 211.84(d)(1)Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.165(b)Testing and release for distribution1
- 21 CFR 211.166(a)(3)Stability testing1
The complete Discus Dental 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
Ontario, California
Two Form 483s · 2015 to 2019 · 11 observations
Latest: Form 483, Oct 17, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-10-17 | 483 Form 483 | Ontario, California | 1 | $99 |
| 2015-11-23 | 483 Form 483 | Ontario, California | 10 | $99 |
Investigators on these documents
FEI number 1000582314 · most recent document Oct 17, 2019
About Discus Dental LLC
How many FDA Form 483s has Discus Dental LLC received?
FDA Intel has 2 Form 483s on file for Discus Dental LLC; the most recent is dated Oct 17, 2019.
When was Discus Dental LLC last inspected by FDA?
The most recent FDA inspection document on file for Discus Dental LLC is a Form 483 dated Oct 17, 2019, for the site in Ontario, California.
What did FDA cite at Discus Dental LLC?
The regulations cited most in the observations on file for Discus Dental LLC are 21 CFR 211.160(a) (General requirements), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.84(d)(1) (Testing and approval or rejection of components, drug product containers, and closures), 2 times.