Xlear Inc
FDA inspection history in American Fork, Utah, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at American Fork, Utah.
Cited most
Across all Xlear observations on file
- 21 CFR 211.84(b)Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.125(a)Labeling issuance1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.166(b)Stability testing1
The complete Xlear file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
American Fork, Utah
One Form 483 · 2022 · 9 observations
Latest: Form 483, Mar 18, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-03-18 | 483 Form 483 | American Fork, Utah | 9 | $99 |
Investigators on these documents
FEI number 3010166224 · most recent document Mar 18, 2022
About Xlear Inc
How many FDA Form 483s has Xlear Inc received?
FDA Intel has 1 Form 483 on file for Xlear Inc; the most recent is dated Mar 18, 2022.
When was Xlear Inc last inspected by FDA?
The most recent FDA inspection document on file for Xlear Inc is a Form 483 dated Mar 18, 2022, for the site in American Fork, Utah.
What did FDA cite at Xlear Inc?
The regulations cited most in the observations on file for Xlear Inc are 21 CFR 211.84(b) (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.111 (Time limitations on production), 1 time; 21 CFR 211.125(a) (Labeling issuance), 1 time.